LAS VEGAS Case Report Form 1 Intra-Operative

Transcription

1 LAS VEGAS Case Report Form 1 Intra-Operative Patient Informed Consent 1. Informed consent applicable: yes no (choose no if waived by local EC) 1.1 If applicable; was consent obtained? yes no 1.2 If yes, Date of informed consent [<Date of surgery]: Demographic data 2. Sex: male female 3. Age [18-110]: years 4. Date of birth [<=14-JAN-1995]: 5. Ethnicity/Race: caucasian black ethnicity pacific islander hispanic native american asian other 6. Height available? yes no 6.1 If yes, specify [ ]: cm 7. Weight available? yes no 7.1 If yes, specify [30-300]: kg 8. ASA score: Functional status: non-dependent partially dependent totally dependent 10. Current smoker: yes no 11. Chronic co-morbidity: yes none 11.1 If yes, tick all that apply liver cirrhosis metastatic cancer chronic kidney failure COPD heart failure obstructive sleep apnea any neuromuscular disease affecting the respiratory system 12. Respiratory infection: < 30 days ago yes no 13. Recent transfusion of PRBC: < 24 hrs ago yes no 13.1 If yes, number of PRBC units [0-20]: units 14. Present MV or recent MV: < 30 days ago yes no 14.1 If yes, indication of MV: Saturation and Laboratory results 15. SpO 2 (pre-operative) available? yes no breathing room air in supine position 15.1 If yes, what is the percentage [0-100]? % Most recent blood results if clinically available (taken no longer than 28 days before surgery): 16. Hb available? yes no 16.1 If yes, specify:. mmol/l [0.5-14] g/dl [0.5-25] choose unit 17. Leukocytes available? yes no 17.1 If yes, specify: x10^9/l [0-60] cells/mm^3 [ ] choose unit 18. Creatinine available? yes no 18.1 If yes, specify:. μmol/l [ ] mg/dl [0.1-11] choose unit LAS VEGAS_CRF1_Intra-Operative, version #2.1 dated 28 September 2012 page 1 of 6

2 Surgical procedure 17. Urgency of surgery: Elective Urgent Emergency 18. Planned duration of surgery (hrs): 2 >2 to 3 > Surgical procedure: tick all that apply Lower gastro-intestinal Kidney Head and Neck Upper gastro-intestinal Urological Plastics / Cutaneous Hepato-biliary / Pancreas Gynaecological surgery Breast Carotid endarterectomy Endocrine surgery Bone & joint surgery Peripheral vascular Transplant Spine Aortic surgery Lung / Pleural surgery Trauma Neurosurgery Other procedure 20. Surgical technique: tick all that apply One-lung ventilation during procedure Open abdominal surgery Open thoracic surgery Laparoscopic surgery Thoracoscopic surgery Laparoscopic assisted Thoracoscopic assisted Peripheral None of the above Intra-operative data 21. Breathing circuit: Open Closed Semi-open Semi-closed 22. Tube type: Endotracheal tube Supra-glottic device (e.g. LMA) choose single most appropriate Endobronchial blocker Double-lumen endotracheal tube via tracheostomy Nasal endotracheal tube 23. Epidural anesthesia: yes no 24. Antibiotic prophylaxis: yes no 25. Neuromuscular monitoring: none TOF 25.1 If TOF, specify monitoring by: EMG MMG AMG choose single most appropriate Duration anesthesia 26. Time & date start induction : [0-23hrs] [0-59min] [>=14FEB-2013] h h m m 27. Time & date extubation or : discharge from OR if MV remains h h m m [0-23hrs] [0-59min] [>=14FEB-2013] Duration surgery 28. Time & date start procedure : [0-23hrs] [0-59min] [>=14FEB-2013] h h m m 29. Time & date stop procedure : [0-23hrs] [0-59min] [>=14FEB-2013] h h m m LAS VEGAS_CRF1_Intra-Operative, version #2.1 dated 28 September 2012 page 2 of 6

3 Intra-Operative Ventilatory settings MV Settings Induction 30. Ventilatory mode tick most appropriate 31. Ppeak [0-60] 32. Pplateau [10-50] if available 33. Pmean [10-50] 34. TV [ mL] 35. PEEP [0-20] 36. RR [1-60/mn] 37. RM 37.1 if yes; tick all that apply yes no Hour 1 VC PC PSV Spon Other yes no VC PC PSV Spon Other Hour 2 yes no Hour 3 VC PC PSV Spon Other yes no VC PC PSV Spon Other Hour 4 yes no Hour 5 VC PC PSV Spon Other yes no Hour 6 VC PC PSV Spon Other yes no Hour 7 VC PC PSV Spon Other yes no VC PC PSV Spon Other LAS VEGAS_CRF1_Intra-Operative, version #2.1 dated 28 September 2012 page 3 of 6

4 Monitored parameter 38. SpO 2 % [0-100] 39. etco 2 [5-100 mmhg] [ kpa] 40. FiO 2 % [20-100] 41. MAPmmHg [20-200] 42. HR bpm [10-300] Induction. tick unit used Hour 1. tick unit used Hour 2. tick unit used Hour 3. tick unit used Hour 4. tick unit used Hour 5. tick unit used Hour 6. tick unit used Hour 7. tick unit used Parameters at end of surgery 43. Temperature available? yes no 43.1 If yes, specify:. o C [ ] o F [ ]choose unit 44. Hb available? yes no 44.1 If yes, specify:. mmol/l [0.5-14] g/dl [0.5-25] choose unit Intra-operative fluids (total during procedure) 45. Crystalloids available? yes no 45.1 If yes, specify [ ]: ml 46. Colloids available? yes no 46.1 If yes, specify [ ]: ml 47. Albumin available? yes no 47.1 If yes, specify [ ]: ml 48. Packed red blood cells available? yes no 48.1 If yes, specify [0-20]: units Intra-operative medication 49. Opioids: yes no 49.1 If yes, specify type: short-acting long-acting choose single most appropriate 50. Hypnotic agents: total intravenous volatile halogenated agents tick all that apply 51. Muscle paralysis agents: yes no 52. Neuromuscular blockade reversal agents: yes no LAS VEGAS_CRF1_Intra-Operative, version #2.1 dated 28 September 2012 page 4 of 6

5 Intra-operative complications Occurrence of complications related to the ventilation strategy during procedure 53. Any de saturation: yes no defined as SpO 2 < 92% 54. Need for unplanned recruitment maneuver: yes no ventilatory strategies aimed to restore lung aeration 55. Need for ventilatory pressure reduction: yes no ventilatory strategies aimed to lower Ppeak/Pplateau 56. New onset of expiratory flow limitation: yes no defined as expiratory flow higher than zero at end-expiration as suggested by visual analysis of the flow curve 57. Hypotension: yes no defined as SAP < 90mmHg for 3 min or longer 58. Need for vaso-active drugs: yes no any vaso-active drug given to correct hypotension 59. Any new arrhythmias: yes no defined as new onset of AF, VT, SVT or VF LAS VEGAS_CRF1_Intra-Operative, version #2.1 dated 28 September 2012 page 5 of 6

6 Guide intra-operative values Urgency surgery: Emergency: non-elective surgery performed when the patient's life or well-being is in direct jeopardy Urgent: surgery required within < 48 hrs Elective: surgery that is scheduled in advance because it does not involve a medical emergency Ventilatory Mode: - Volume Control: VC - Pressure Control: PC - Pressure Support: PSV - Spontaneous: Spon - Other (for example HFOV, jet ventilation, SIMV) Recruitment Maneuvers (RM): - Incremental PEEP (PEEP): stepwise increases in PEEP at constant tidal volume, mostly in steps of 5 cmh 20, until peak/plateau positive airway pressure above 30 cmh 20 is reached. PEEP is sustained for 3 or more breaths and then returned back to baseline ventilation. - Tidal volume recruitment (TV): stepwise increases in tidal volume until peak/plateau positive airway pressure above 30 cmh 20 is reached at constant PEEP level. At least 3 breaths with the plateau pressure of above 30 cmh 20 are performed, before returning back to baseline ventilation. - Combined tidal and PEEP recruitment (TV/PEEP): PEEP and tidal volume are both stepwise increased to reach a plateau pressure above 30 cmh 20. At least 3 breaths with the plateau pressure > 30 cmh 20 are performed, before returning back to baseline ventilation. - Inspiratory holds (Insp): also called CPAP maneuvers. During this kind of maneuver a positive airway pressure above 30 cmh 20 is applied for 10 to 30 seconds and then returned back to baseline ventilation. - Sustained inflation with bag (Bag): manual hyperinflation using balloon/bag. New onset arrhythmias: Defined as new onset of atrial fibrillation [AF], sustained ventricular tachycardia [VT], supraventricular tachycardia [SVT], and ventricular fibrillation [VF]. For further definitions of AF, VT, SVT and VF; see Appendix 1 of protocol Neuromuscular function evaluation for residual curarization: Train-of-four stimulation (TOF) TOF ratio measured by: - electromyography (EMG) - mechanomyography (MMG) - acceleromyography (AMG) Opioids: Short-acting: remifentanil, alfentanil Long-acting: fentanil, sufentanil, morphine LAS VEGAS_CRF1_Intra-Operative, version #2.1 dated 28 September 2012 page 6 of 6

7 LAS VEGAS Case Report Form 2A - Non Critical Care Follow up DAY 0 Post-Operative Time: from end of surgery to 23:59h 1. Day 0 follow up performed? yes no 2. If yes, date [=Date of surgery]: Post-operative residual curarization 3. Post-operative residual curarization: yes no defined as TOF ratio < If yes, specify type of TOF monitoring: EMG MMG AMG choose single most appropriate 4. Neuromuscular blockade antagonized? yes no Pulmonary complications 5. Need for O 2 therapy? need for O 2 standard care no due to PaO 2 <60 mmhg or SpO 2 <90% in room air or standard care in PACU 5.1 If O 2 is supplemented, specify FiO 2 [20-100] % conversion O 2 to FiO 2; see Appendix 2 in protocol 6. Respiratory failure? yes no PaO 2 < 60 mmhg or SpO 2 < 90% despite O 2 therapy or need for non-invasive MV (NIV) 6.1 If NIV is applied, specify type of interface mask helmet 7. Pneumonia? new no presence of new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leukocytosis or leucopenia and purulent secretions) 8. ARDS? new no according to Berlin definition of ARDS 9. Pneumothorax? new no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Clinical course 10. MV after exit operating room? yes no 10.1 If yes, MV continuated after exit operating room, specify: planned unplanned 10.2 If unplanned: continued re-intubation 11. Critical Care admission directly after surgery? yes no 11.1 If yes, specify planned or unplanned: planned unplanned Lost to follow-up 12. Lost to follow-up? yes no 12.1 If yes, specify: discharge to home informed consent retracted deceased transfer to other hospital other 12.2 If other, specify reason: In case of Critical Care admission or prolonged MV please: complete this page and then proceed to CRF 2B, page 1 LAS VEGAS_CRF2A_Non Critical Care F/U, Final version #2.1 dated 28 September 2012 page 1 of 6

8 1. Day 1 follow up performed? yes no 2. If yes, date [=Date of surgery+1]: Pulmonary complications 3. Need for O 2 therapy? new O 2 continued standard care no due to PaO 2 < 60 mmhg or SpO 2 < 90% in room air or standard care 3.1 If O 2 is supplemented, specify FiO 2 [20-100] % conversion O 2 to FiO 2; see Appendix 2 in protocol 4. Respiratory failure? new continued no PaO 2 < 60 mmhg or SpO 2 < 90% despite O 2 therapy or need for non-invasive MV (NIV) 4.1 If NIV is applied, specify type of interface mask helmet 5. Pneumonia? new continued no presence of new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leukocytosis or leucopenia and purulent secretions) 6. ARDS? new continued no according to Berlin definition of ARDS 7. Pneumothorax? new continued no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Clinical course LAS VEGAS Non Critical Care Follow up DAY 1 Post-Operative Time: from 00:00h to 23:59h 8. Any new mechanical ventilation? yes no 9. Any new admission to Critical Care? yes no Lost to follow-up 10. Lost to follow-up? yes no 10.1 If yes, specify: discharge to home informed consent retracted deceased transfer to other hospital other 10.2 If other, specify reason: In case of Critical Care admission or prolonged MV please: complete this page and then proceed to CRF 2B, page 1 LAS VEGAS_CRF2A_Non Critical Care F/U, Final version #2.1 dated 28 September 2012 page 2 of 6

9 1. Day 2 follow up performed? yes no 2. If yes, date [=Date of surgery+1]: Pulmonary complications 3. Need for O 2 therapy? new O 2 continued standard care no due to PaO 2 < 60 mmhg or SpO 2 < 90% in room air or standard care 3.1 If O 2 is supplemented, specify FiO 2 [20-100] % conversion O 2 to FiO 2; see Appendix 2 in protocol 4. Respiratory failure? new continued no PaO 2 < 60 mmhg or SpO 2 < 90% despite O 2 therapy or need for non-invasive MV (NIV) 4.1 If NIV is applied, specify type of interface mask helmet 5. Pneumonia? new continued no presence of new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leukocytosis or leucopenia and purulent secretions) 6. ARDS? new continued no according to Berlin definition of ARDS 7. Pneumothorax? new continued no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Clinical course LAS VEGAS Non Critical Care Follow up DAY 2 Post-Operative Time: from 00:00h to 23:59h 8. Any new mechanical ventilation? yes no 9. Any new admission to Critical Care? yes no Lost to follow-up 10. Lost to follow-up? yes no 10.1 If yes, specify: discharge to home informed consent retracted deceased transfer to other hospital other 10.2 If other, specify reason: In case of Critical Care admission or prolonged MV please: complete this page and then proceed to CRF 2B, page 1 LAS VEGAS_CRF2A_Non Critical Care F/U, Final version #2.1 dated 28 September 2012 page 3 of 6

10 LAS VEGAS Non Critical Care Follow up DAY 3 Post-Operative Time: from 00:00h to 23:59h 1. Day 3 follow up performed? yes no 2. If yes, date [=Date of surgery+1]: Pulmonary complications 3. Need for O 2 therapy? new O 2 continued standard care no due to PaO 2 < 60 mmhg or SpO 2 < 90% in room air or standard care 3.1 If O 2 is supplemented, specify FiO 2 [20-100] % conversion O 2 to FiO 2; see Appendix 2 in protocol 4. Respiratory failure? new continued no PaO 2 < 60 mmhg or SpO 2 < 90% despite O 2 therapy or need for non-invasive MV (NIV) 4.1 If NIV is applied, specify type of interface mask helmet 5. Pneumonia? new continued no presence of new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leukocytosis or leucopenia and purulent secretions) 6. ARDS? new continued no according to Berlin definition of ARDS 7. Pneumothorax? new continued no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Clinical course 8. Any new mechanical ventilation? yes no 9. Any new admission to Critical Care? yes no Lost to follow-up 10. Lost to follow-up? yes no 10.1 If yes, specify: discharge to home informed consent retracted deceased transfer to other hospital other 10.2 If other, specify reason: In case of Critical Care admission or prolonged MV please: complete this page and then proceed to CRF 2B, page 1 LAS VEGAS_CRF2A_Non Critical Care F/U, Final version #2.1 dated 28 September 2012 page 4 of 6

11 1. Day 4 follow up performed? yes no 2. If yes, date [=Date of surgery+1]: Pulmonary complications 3. Need for O2 therapy? new O 2 continued standard care no due to PaO 2 < 60 mmhg or SpO 2 < 90% in room air or standard care 3.1 If O 2 is supplemented, specify FiO 2 [20-100] % conversion O 2 to FiO 2; see Appendix 2 in protocol 4. Respiratory failure? new continued no PaO 2 < 60 mmhg or SpO 2 < 90% despite O 2 therapy or need for non-invasive MV (NIV) 4.1 If NIV is applied, specify type of interface mask helmet 5. Pneumonia? new continued no presence of new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leukocytosis or leucopenia and purulent secretions) 6. ARDS? new continued no according to Berlin definition of ARDS 7. Pneumothorax? new continued no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Clinical course 8. Any new mechanical ventilation? yes no 9. Any new admission to Critical Care? yes no Lost to follow-up LAS VEGAS Non Critical Care Follow up DAY 4 Post-Operative Time: from 00:00h to 23:59h 10. Lost to follow-up? yes no 10.1 If yes, specify: discharge to home informed consent retracted deceased transfer to other hospital other 10.2 If other, specify reason: In case of Critical Care admission or prolonged MV please: complete this page and then proceed to CRF 2B, page 1 LAS VEGAS_CRF2A_Non Critical Care F/U, Final version #2.1 dated 28 September 2012 page 5 of 6

12 1. Day 5 follow up performed? yes no 2. If yes, date [=Date of surgery+1]: Pulmonary complications 3. Need for O2 therapy? new O 2 continued standard care no due to PaO 2 < 60 mmhg or SpO 2 < 90% in room air or standard care 3.1 If O 2 is supplemented, specify FiO 2 [20-100] % conversion O 2 to FiO 2; see Appendix 2 in protocol 4. Respiratory failure? new continued no PaO 2 < 60 mmhg or SpO 2 < 90% despite O 2 therapy or need for non-invasive MV (NIV) 4.1 If NIV is applied, specify type of interface mask helmet 5. Pneumonia? new continued no presence of new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leukocytosis or leucopenia and purulent secretions) 6. ARDS? new continued no according to Berlin definition of ARDS 7. Pneumothorax? new continued no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Clinical course LAS VEGAS Non Critical Care Follow up DAY 5 Post-Operative Time: from 00:00h to 23:59h 8. Any new mechanical ventilation? yes no 9. Any new admission to Critical Care? yes no Lost to follow-up 10. Lost to follow-up? yes no 10.1 If yes, specify: discharge to home informed consent retracted deceased transfer to other hospital other 10.2 If other, specify reason: In case of Critical Care admission or prolonged MV please: complete this page and then proceed to CRF 2B, page 1 LAS VEGAS_CRF2A_Non Critical Care F/U, Final version #2.1 dated 28 September 2012 page 6 of 6

13 LAS VEGAS Case Report Form 2B - Critical Care Follow up (F/U) Admission Every investigator should fill this page for every patient admitted to Critical Care Admission to Critical Care 1. ICU Admission day: day 0 day 1 day 2 day 3 day 4 day 5 Reason(s) for Critical Care admission: tick all that apply 2. Respiratory failure yes no 3. Need for intensive monitoring yes no 4. Circulatory failure yes no 5. Routine care (i.e. planned) yes no 6. Airway protection yes no 7. Respiratory arrest in 24 hours prior to Critical Care admission yes no 8. Cardiac arrest in 24 hours prior to Critical Care admission yes no Mechanical Ventilation (invasive or non-invasive) 9. Invasive mechanical ventilation? yes no 10. Non-invasive mechanical ventilation? yes no If yes, specify type of interface mask helmet Reason(s) for Mechanical Ventilation: 11. Respiratory failure yes no 12. Pneumonia yes no 13. Aspiration yes no 14. Cardiac overload yes no 15. Airway protection yes no 16. Fatigue yes no 17. Coma (GCS<6) yes no 18. Post-Operative MV yes no If you have chosen to perform Critical Care follow-up, please continue data-entry on the F/U page corresponding with ICU admission day E.g. if patient is transferred to ICU on day 3; fill in Critical Care F/U for day 3 (page 8) and mark day 0, 1 and 2 not performed LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 1 of 14

14 LAS VEGAS Critical Care Follow up DAY 0 Post-Operative Time: from end of surgery to 23:59h 1. Day 0 follow up performed? yes no 2. If yes, date [>=14-FEB-2013]: 3. APACHE II score [0-71]: in case of new admission (score within first 24h) Daily score (at first hour of Critical Care admission) 4. SOFA score [0-24]: 5. Invasive mechanical ventilation? yes no 5.1 Total hours of invasive MV [0-24]: hours from end of surgery to 23:59h 6. Non-invasive mechanical ventilation? yes no 6.1 If non-invasive, specify type of interface mask helmet 6.2 Total hours of non-invasive MV [0-24]: hours from end of surgery to 23:59h 7. Tracheal extubation on day 0? n/a yes no 8. Re-intubation on day 0? n/a yes no Mechanical Ventilation from end of surgery to 23:59h 9. Hours of controlled MV [0-24]: hours i.e. pressure control; volume control 10. Hours of assisted MV [0-24]: hours i.e. ASB 11. Hours of combined controlled/assisted MV [0-24]: hours i.e. ASV, SIMV 12. Hours of CPAP [0-24]: hours Ppeak [20-60 cmh2o] Pplat (if available) [10-50 cmh2o] TV [ ml] PEEP [0-30 cmh2o] Resp Rate [1-60 /min] Highest Lowest Highest Lowest Highest Lowest Highest Lowest Highest Lowest RM FiO2 [20-100%] ph [ ] PaCO2 [ mmhg] or [1-40 kpa] PaO2 [ mmhg] or [1-80 kpa] Yes* No Highest Lowest Highest Lowest Highest Lowest Highest Lowest 23.1 *if yes, tick all that apply LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 2 of 14

15 Extra-pulmonary organ failure 32. Pneumonia? yes no presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leucocytosis or leucopenia and purulent secretions) 33. ARDS? yes no 33.1 If yes, specify severity of ARDS mild moderate severe according to Berlin definition of ARDS 34. Pneumothorax? yes no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Extra-pulmonary organ failure 35. Acute kidney failure? yes no 35.1 If yes, staging by RIFLE criteria risk injury failure loss end-stage definitions on page Renal replacement therapy? yes no 37. Circulatory failure? yes no defined as; need for vaso-active drugs 38. Any new arrhythmias? yes no definition on page 14 Transfusion of fluids 39. Transfusion PRBC? yes no 39.1 Number of PRBC units given [0-20]: 40. Transfusion Fresh Frozen Plasma? yes no 40.1 Number of FFP units given [0-20]: 41. Transfusion platelets? yes no 41.1 Number of platelets units given [1-5]: 42. Fluid balance available? yes no 42.1 If yes, specify volume [ ]: ml 42.2 If yes, balance positive or negative positive negative End of Critical Care stay / Lost to follow-up 43. End of CriticaI Care stay? yes no 43.1 If yes, specify: discharge to ward transfer to other hospital deceased discharge to home 44. At end of CriticaI Care stay, specify total duration of stay [0-144]: hours 45. Lost to follow-up? yes no 45.1 If yes, specify: informed consent retracted other 45.2 If other, specify reason: If discharge to ward; please continue data recording on CRF 2A Non Critical Care LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 3 of 14

16 LAS VEGAS Critical Care Follow up DAY 1 Post-Operative Time: from 00:00 h to 23:59h 1. Day 1 follow up performed? yes no 2. If yes, date [>14-FEB-2013]: 3. APACHE II score [0-71]: If APACHE II is already scored on a previous day, in case of new admission (score within first 24h) please fill 00 Daily score (on morning round; i.e. closest to 08:00 AM. In case of new admission at first hour of CCU admission) 4. SOFA score [0-24]: 5. Invasive mechanical ventilation? yes no 5.1 Total hours of invasive MV [0-24]: hours from 00:00h to 23:59h 6. Non-invasive mechanical ventilation? yes no 6.1 If non-invasive, specify type of interface mask helmet 6.2 Total hours of non-invasive MV [0-24]: hours from 00:00h to 23:59h 7. Tracheal extubation on day 1? n/a yes no 8. Re-intubation on day 1? n/a yes no Mechanical Ventilation from 00:00 h to 23:59h 46. Hours of controlled MV [0-24]: hours i.e. pressure control; volume control 47. Hours of assisted MV [0-24]: hours i.e. ASB 48. Hours of combined controlled/assisted MV [0-24]: hours i.e. ASV, SIMV 49. Hours of CPAP [0-24]: hours Ppeak [20-60 cmh2o] Pplat (if available) [10-50 cmh2o] TV [ ml] PEEP [0-30 cmh2o] Resp Rate [1-60 /min] Highest Lowest Highest Lowest Highest Lowest Highest Lowest Highest Lowest RM FiO2 [20-100%] ph [ ] PaCO2 [ mmhg] or [1-40 kpa] PaO2 [ mmhg] or [1-80 kpa] Yes* No Highest Lowest Highest Lowest Highest Lowest Highest Lowest 60.1 *if yes, tick all that apply LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 4 of 14

17 Pulmonary complications 9. Pneumonia? yes no presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leucocytosis or leucopenia and purulent secretions) 10. ARDS? yes no 10.1 If yes, specify severity of ARDS mild moderate severe according to Berlin definition of ARDS 11. Pneumothorax? yes no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Extra-pulmonary organ failure 12. Acute kidney failure? yes no 12.1 If yes, staging by RIFLE criteria risk injury failure loss end-stage definitions on page Renal replacement therapy? yes no 14. Circulatory failure? yes no defined as; need for vaso-active drugs 15. Any new arrhythmias? yes no definition on page 14 Transfusion of fluids 16. Transfusion PRBC? yes no 16.1 Number of PRBC units given [0-20]: 17. Transfusion Fresh Frozen Plasma? yes no 17.1 Number of FFP units given [0-20]: 18. Transfusion platelets? yes no 18.1 Number of platelets units given [1-5]: 19. Fluid balance available? yes no 19.1 If yes, specify volume [ ]: ml 19.2 If yes, balance positive or negative positive negative End of Critical Care stay / Lost to follow-up 20. End of CriticaI Care stay? yes no 20.1 If yes, specify: discharge to ward transfer to other hospital deceased discharge to home 21. At end of CriticaI Care stay, specify total duration of stay [0-144]: hours 22. Lost to follow-up? yes no 22.1 If yes, specify: informed consent retracted other 22.2 If other, specify reason: If discharge to ward; please continue data recording on CRF 2A Non Critical Care Follow up LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 5 of 14

18 LAS VEGAS Critical Care Follow up DAY 2 Post-Operative Time: from 00:00 h to 23:59h 1. Day 2 follow up performed? yes no 2. If yes, date [>14-FEB-2013]: 3. APACHE II score [0-71]: If APACHE II is already scored on a previous day, in case of new admission (score within first 24h) please fill 00 Daily score (on morning round; i.e. closest to 08:00 AM. In case of new admission at first hour of CCU admission) 23. SOFA score [0-24]: 24. Invasive mechanical ventilation? yes no 24.1 Total hours of invasive MV [0-24]: hours from 00:00h to 23:59h 25. Non-invasive mechanical ventilation? yes no 25.1 If non-invasive, specify type of interface mask helmet 25.2 Total hours of non-invasive MV [0-24]: hours from 00:00h to 23:59h 26. Tracheal extubation on day 2? n/a yes no 27. Re-intubation on day 2? n/a yes no Mechanical Ventilation from 00:00 h to 23:59h 69. Hours of controlled MV [0-24]: hours i.e. pressure control; volume control 70. Hours of assisted MV [0-24]: hours i.e. ASB 71. Hours of combined controlled/assisted MV [0-24]: hours i.e. ASV, SIMV 72. Hours of CPAP [0-24]: hours Ppeak [20-60 cmh2o] Pplat (if available) [10-50 cmh2o] TV [ ml] PEEP [0-30 cmh2o] Resp Rate [1-60 /min] Highest Lowest Highest Lowest Highest Lowest Highest Lowest Highest Lowest RM FiO2 [20-100%] ph [ ] PaCO2 [ mmhg] or [1-40 kpa] PaO2 [ mmhg] or [1-80 kpa] Yes* No Highest Lowest Highest Lowest Highest Lowest Highest Lowest 83.1 *if yes, tick all that apply LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 6 of 14

19 Pulmonary complications 28. Pneumonia? yes no presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leucocytosis or leucopenia and purulent secretions) 29. ARDS? yes no 29.1 If yes, specify severity of ARDS mild moderate severe according to Berlin definition of ARDS 30. Pneumothorax? yes no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Extra-pulmonary organ failure 31. Acute kidney failure? yes no 31.1 If yes, staging by RIFLE criteria risk injury failure loss end-stage definitions on page Renal replacement therapy? yes no 33. Circulatory failure? yes no defined as; need for vaso-active drugs 34. Any new arrhythmias? yes no definition on page 14 Transfusion of fluids 35. Transfusion PRBC? yes no 35.1 Number of PRBC units given [0-20]: 36. Transfusion Fresh Frozen Plasma? yes no 36.1 Number of FFP units given [0-20]: 37. Transfusion platelets? yes no 37.1 Number of platelets units given [1-5]: 38. Fluid balance available? yes no 38.1 If yes, specify volume [ ]: ml 38.2 If yes, balance positive or negative positive negative End of Critical Care stay / Lost to follow-up 39. End of CriticaI Care stay? yes no 39.1 If yes, specify: discharge to ward transfer to other hospital deceased discharge to home 40. At end of CriticaI Care stay, specify total duration of stay [0-144]: hours 41. Lost to follow-up? yes no 41.1 If yes, specify: informed consent retracted other 41.2 If other, specify reason: If discharge to ward; please continue data recording on CRF 2A Non Critical Care Follow Up LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 7 of 14

20 LAS VEGAS Critical Care Follow up DAY 3 Post-Operative Time: from 00:00 h to 23:59h 1. Day 3 follow up performed? yes no 2. If yes, date [>14-FEB-2013]: 3. APACHE II score [0-71]: If APACHE II is already scored on a previous day, in case of new admission (score within first 24h) please fill 00 Daily score (on morning round; i.e. closest to 08:00 AM. In case of new admission at first hour of CCU admission) 1. SOFA score [0-24]: 2. Invasive mechanical ventilation? yes no 2.1 Total hours of invasive MV [0-24]: hours from 00:00h to 23:59h 3. Non-invasive mechanical ventilation? yes no 3.1 If non-invasive, specify type of interface mask helmet 3.2 Total hours of non-invasive MV [0-24]: hours from 00:00h to 23:59h 4. Tracheal extubation on day 3? n/a yes no 5. Re-intubation on day 3? n/a yes no Mechanical Ventilation from 00:00 h to 23:59h 92. Hours of controlled MV [0-24]: hours i.e. pressure control; volume control 93. Hours of assisted MV [0-24]: hours i.e. ASB 94. Hours of combined controlled/assisted MV [0-24]: hours i.e. ASV, SIMV 95. Hours of CPAP [0-24]: hours Ppeak [20-60 cmh2o] Pplat (if available) [10-50 cmh2o] TV [ ml] PEEP [0-30 cmh2o] Resp Rate [1-60 /min] Highest Lowest Highest Lowest Highest Lowest Highest Lowest Highest Lowest RM FiO2 [20-100%] ph [ ] PaCO2 [ mmhg] or [1-40 kpa] PaO2 [ mmhg] or [1-80 kpa] Yes* No Highest Lowest Highest Lowest Highest Lowest Highest Lowest *if yes, tick all that apply LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 8 of 14

21 Pulmonary complications 6. Pneumonia? yes no presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leucocytosis or leucopenia and purulent secretions) 7. ARDS? yes no 7.1 If yes, specify severity of ARDS mild moderate severe according to Berlin definition of ARDS 8. Pneumothorax? yes no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Extra-pulmonary organ failure 9. Acute kidney failure? yes no 9.1 If yes, staging by RIFLE criteria risk injury failure loss end-stage definitions on page Renal replacement therapy? yes no 11. Circulatory failure? yes no defined as; need for vaso-active drugs 12. Any new arrhythmias? yes no definition on page 14 Transfusion of fluids 13. Transfusion PRBC? yes no 13.1 Number of PRBC units given [0-20]: 14. Transfusion Fresh Frozen Plasma? yes no 14.1 Number of FFP units given [0-20]: 15. Transfusion platelets? yes no 15.1 Number of platelets units given [1-5]: 16. Fluid balance available? yes no 16.1 If yes, specify volume [ ]: ml 16.2 If yes, balance positive or negative positive negative End of Critical Care stay / Lost to follow-up 17. End of CriticaI Care stay? yes no 17.1 If yes, specify: discharge to ward transfer to other hospital deceased discharge to home 18. At end of CriticaI Care stay, specify total duration of stay [0-144]: hours 19. Lost to follow-up? yes no 19.1 If yes, specify: informed consent retracted other 19.2 If other, specify reason: If discharge to ward; please continue data recording on CRF 2A Non Critical Care Follow Up LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 9 of 14

22 LAS VEGAS Critical Care Follow up DAY 4 Post-Operative Time: from 00:00 h to 23:59h 1. Day 4 follow up performed? yes no 2. If yes, date [>14-FEB-2013]: 3. APACHE II score [0-71]: If APACHE II is already scored on a previous day, in case of new admission (score within first 24h) please fill 00 Daily score (on morning round; i.e. closest to 08:00 AM. In case of new admission at first hour of CCU admission) 1. SOFA score [0-24]: 2. Invasive mechanical ventilation? yes no 2.1 Total hours of invasive MV [0-24]: hours from 00:00h to 23:59h 3. Non-invasive mechanical ventilation? yes no 3.1 If non-invasive, specify type of interface mask helmet 3.2 Total hours of non-invasive MV [0-24]: hours from 00:00h to 23:59h 4. Tracheal extubation on day 4? n/a yes no 5. Re-intubation on day 4? n/a yes no Mechanical Ventilation from 00:00 h to 23:59h 115. Hours of controlled MV [0-24]: hours i.e. pressure control; volume control 116. Hours of assisted MV [0-24]: hours i.e. ASB 117. Hours of combined controlled/assisted MV [0-24]: hours i.e. ASV, SIMV 118. Hours of CPAP [0-24]: hours Ppeak [20-60 cmh2o] Pplat (if available) [10-50 cmh2o] TV [ ml] PEEP [0-30 cmh2o] Resp Rate [1-60 /min] Highest Lowest Highest Lowest Highest Lowest Highest Lowest Highest Lowest RM FiO2 [20-100%] ph [ ] PaCO2 [ mmhg] or [1-40 kpa] PaO2 [ mmhg] or [1-80 kpa] Yes* No Highest Lowest Highest Lowest Highest Lowest Highest Lowest *if yes, tick all that apply LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 10 of 14

23 Pulmonary complications 6. Pneumonia? yes no presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leucocytosis or leucopenia and purulent secretions) 7. ARDS? yes no 7.1 If yes, specify severity of ARDS mild moderate severe according to Berlin definition of ARDS 8. Pneumothorax? yes no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Extra-pulmonary organ failure 9. Acute kidney failure? yes no 9.1 If yes, staging by RIFLE criteria risk injury failure loss end-stage definitions on page Renal replacement therapy? yes no 11. Circulatory failure? yes no defined as; need for vaso-active drugs 12. Any new arrhythmias? yes no definition on page 14 Transfusion of fluids 13. Transfusion PRBC? yes no 13.1 Number of PRBC units given [0-20]: 14. Transfusion Fresh Frozen Plasma? yes no 14.1 Number of FFP units given [0-20]: 15. Transfusion platelets? yes no 15.1 Number of platelets units given [1-5]: 16. Fluid balance available? yes no 16.1 If yes, specify volume [ ]: ml 16.2 If yes, balance positive or negative positive negative End of Critical Care stay / Lost to follow-up 17. End of CriticaI Care stay? yes no 17.1 If yes, specify: discharge to ward transfer to other hospital deceased discharge to home 18. At end of CriticaI Care stay, specify total duration of stay [0-144]: hours 19. Lost to follow-up? yes no 19.1 If yes, specify: informed consent retracted other 19.2 If other, specify reason: If discharge to ward; please continue data recording on CRF 2A Non Critical Care Follow Up LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 11 of 14

24 LAS VEGAS Critical Care Follow up DAY 5 Post-Operative Time: from 00:00 h to 23:59h 1. Day 5 follow up performed? yes no 2. If yes, date [>14-FEB-2013]: 3. APACHE II score [0-71]: If APACHE II is already scored on a previous day, in case of new admission (score within first 24h) please fill 00 Daily score (on morning round; i.e. closest to 08:00 AM. In case of new admission at first hour of CCU admission) 1. SOFA score [0-24]: 2. Invasive mechanical ventilation? yes no 2.1 Total hours of invasive MV [0-24]: hours from 00:00h to 23:59h 3. Non-invasive mechanical ventilation? yes no 3.1 If non-invasive, specify type of interface mask helmet 3.2 Total hours of non-invasive MV [0-24]: hours from 00:00h to 23:59h 4. Tracheal extubation on day 5? n/a yes no 5. Re-intubation on day 5? n/a yes no Mechanical Ventilation from 00:00 h to 23:59h 138. Hours of controlled MV [0-24]: hours i.e. pressure control; volume control 139. Hours of assisted MV [0-24]: hours i.e. ASB 140. Hours of combined controlled/assisted MV [0-24]: hours i.e. ASV, SIMV 141. Hours of CPAP [0-24]: hours Ppeak [20-60 cmh2o] Pplat (if available) [10-50 cmh2o] TV [ ml] PEEP [0-30 cmh2o] Resp Rate [1-60 /min] Highest Lowest Highest Lowest Highest Lowest Highest Lowest Highest Lowest RM FiO2 [20-100%] ph [ ] PaCO2 [ mmhg] or [1-40 kpa] PaO2 [ mmhg] or [1-80 kpa] Yes* No Highest Lowest Highest Lowest Highest Lowest Highest Lowest *if yes, tick all that apply LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 12 of 14

25 Pulmonary complications 6. Pneumonia? yes no presence of a new or progressive radiographic infiltrate plus at least two of three clinical features (fever >38 C or >100.4 F, leucocytosis or leucopenia and purulent secretions) 7. ARDS? yes no 7.1 If yes, specify severity of ARDS mild moderate severe according to Berlin definition of ARDS 8. Pneumothorax? yes no air in the pleural space with no vascular bed surrounding the visceral pleura on CXR Extra-pulmonary organ failure 9. Acute kidney failure? yes no 9.1 If yes, staging by RIFLE criteria risk injury failure loss end-stage definitions on page Renal replacement therapy? yes no 11. Circulatory failure? yes no defined as; need for vaso-active drugs 12. Any new arrhythmias? yes no definition on page 14 Transfusion of fluids 13. Transfusion PRBC? yes no 13.1 Number of PRBC units given [0-20]: 14. Transfusion Fresh Frozen Plasma? yes no 14.1 Number of FFP units given [0-20]: 15. Transfusion platelets? yes no 15.1 Number of platelets units given [1-5]: 16. Fluid balance available? yes no 16.1 If yes, specify volume [ ]: ml 16.2 If yes, balance positive or negative positive negative End of Critical Care stay / Lost to follow-up 17. End of CriticaI Care stay? yes no 17.1 If yes, specify: discharge to ward transfer to other hospital deceased discharge to home 18. At end of CriticaI Care stay, specify total duration of stay [0-144]: hours 19. Lost to follow-up? yes no 19.1 If yes, specify: informed consent retracted other 19.2 If other, specify reason: If discharge to ward; please continue data recording on CRF 2A Non Critical Care Follow Up LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 13 of 14

26 Ventilatory Modes Guide intra-operative values - Volume Control: VC - Pressure Control: PC - Pressure Support Ventilation: PSV - Adaptive Support Ventilation: ASV - Synchronized Intermittend Mandatory Ventilation: SIMV - Assisted Spontaneous Breathing: ASB - Other (for example high frequency oscillatory ventilation (HFOV), jet ventilation) Recruitment Maneuvers (RM) - Incremental PEEP (PEEP): stepwise increases in PEEP at constant tidal volume, mostly in steps of 5 cmh 20, until peak/plateau positive airway pressure above 30 cmh 20 is reached. PEEP is sustained for 3 or more breaths and then returned back to baseline ventilation. - Tidal volume recruitment (TV): stepwise increases in tidal volume until peak/plateau positive airway pressure above 30 cmh 20 is reached at constant PEEP level. At least 3 breaths with the plateau pressure of above 30 cmh 20 are performed, before returning back to baseline ventilation. - Combined tidal and PEEP recruitment (TV/PEEP): PEEP and tidal volume are both stepwise increased to reach a plateau pressure above 30 cmh 20. At least 3 breaths with the plateau pressure > 30 cmh 20 are performed, before returning back to baseline ventilation. - Inspiratory holds (Insp): also called CPAP maneuvers. During this kind of maneuver a positive airway pressure above 30 cmh 20 is applied for 10 to 30 seconds and then returned back to baseline ventilation. - Sustained inflation with bag (Bag): manual hyperinflation using balloon/bag New onset arrhythmias: Defined as new onset of atrial fibrillation [AF], sustained ventricular tachycardia [VT], supraventricular tachycardia [SVT], and ventricular fibrillation [VF]. For further definitions of AF, VT, SVT and VF; see Appendix 1 of protocol The RIFLE criteria, staging of patients with acute kidney injury: - Risk: GFR decrease >25%, serum creatinine increased 1.5 times or urine production of <0.5 ml/kg/hr for 6 hours - Injury: GFR decrease >50%, doubling of creatinine or urine production <0.5 ml/kg/hr for 12 hours - Failure: GFR decrease >75%, tripling of creatinine or creatinine >355 μmol/l (with a rise of >44) (>4 mg/dl) OR urine output below 0.3 ml/kg/hr for 24 hours - Loss: persistent AKI or complete loss of kidney function for more than 4 weeks - End-stage renal disease: complete loss of kidney function for more than 3 months LAS VEGAS_CRF2B_Critical Care F/U, Final version #2.1 dated 28 September 2012 page 14 of 14

27 LAS VEGAS Case Report Form 3 - DAY Day 28 follow up performed? yes no 2. Date day 28: [>=14-MAR-2013]: Hospital discharge or death 3. Patient status at day 28: alive in hospital ward alive in critical care unit choose single most appropriate alive discharged dead 3.1 Date of Hospital discharge or In Hospital death: [>=14-FEB-2013] if discharged or dead LAS VEGAS_CRF3_Day 28, Final version #2.1 dated 28 September 2012 page 1 of 1