A PROTOCOL FOR PRONING. Martin Cieslak

Transcription

1 A PROTOCOL FOR PRONING Martin Cieslak

2 OUTLINE Background Rationale Update

3 BACKGROUND The new england journal of medicine established in 1812 june 6, 2013 vol. 368 no. 23 Prone Positioning in Severe Acute Respiratory Distress Syndrome Claude Guérin, M.D., Ph.D., Jean Reignier, M.D., Ph.D., Jean-Christophe Richard, M.D., Ph.D., Pascal Beuret, M.D., Arnaud Gacouin, M.D., Thierry Boulain, M.D., Emmanuelle Mercier, M.D., Michel Badet, M.D., Alain Mercat, M.D., Ph.D., Olivier Baudin, M.D., Marc Clavel, M.D., Delphine Chatellier, M.D., Samir Jaber, M.D., Ph.D., Sylvène Rosselli, M.D., Jordi Mancebo, M.D., Ph.D., Michel Sirodot, M.D., Gilles Hilbert, M.D., Ph.D., Christian Bengler, M.D., Jack Richecoeur, M.D., Marc Gainnier, M.D., Ph.D., Frédérique Bayle, M.D., Gael Bourdin, M.D., Véronique Leray, M.D., Raphaele Girard, M.D., Loredana Baboi, Ph.D., and Louis Ayzac, M.D., for the PROSEVA Study Group*

4 2013 PROSEVA TRIAL Cumulative Probability of Survival No. at Risk Prone group Supine group P< Days Prone group Supine group Multicenter RCT 466 patients Early and prolonged proning with lung protective ventilation in severe ARDS Absolute 16.8% 28day mortality benefit NNT=6! Figure 2. Kaplan Meier Plot of the Probability of Survival from Randomization to Day 90.

5 TABLE 2. Adverse Events Related to Prone Positioning Treatment Effect (Random-Effect Model) Heterogeneity Adverse Events No. of Trials Reporting the Outcome Events/Prone Events/ Supine OR (95% CI) p Number Needed to Treat/Number Needed to Harm I 2 (%) p Ventilatorassociated pneumonia 6 120/ / ( ) Pressure ulcers 6 294/ / ( ) Major airway 9 255/1, /1, ( ) problem a Unplanned extubation Selective intubation Endotracheal tube obstruction Loss of venous or arterial access Thoracostomy tube dislodgement or kinking 7 113/1,091 98/1, ( ) /642 5/ ( ) /823 77/ ( ) < /407 22/ ( ) /407 14/ ( ) , Pneumothorax 4 29/513 33/ ( ) Cardiac arrest 3 104/ / ( ) Tachyarrhythmia or bradyarrhythmia 3 115/ / ( ) Critical Care Medicine May 2014 Vol 42-5

6 ROYAL COLLEGE Check!

7 META ANALYSIS CMAJ Research CMAJ, July 8, 2014, 186(10) Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis Sachin Sud MD MSc, Jan O. Friedrich MD DPhil, Neill K. J. Adhikari MDCM MSc, Paolo Taccone MD, Jordi Mancebo MD, Federico Polli MD, Roberto Latini MD, Antonio Pesenti MD, Martha A.Q. Curley RN PhD, Rafael Fernandez MD, Ming-Cheng Chan MD, Pascal Beuret MD, Gregor Voggenreiter MD, Maneesh Sud MD, Gianni Tognoni MD, Luciano Gattinoni MD, Claude Guérin MD PhD

8 Table 1: Characteristics of randomized controlled trials included in the systematic review* Study No. of patients Enrolment criteria Patient characteristics at baseline Mean PaO2/FIO2 ratio, mm Hg Mean PEEP, cm H2O Mean FIO2, % Duration of ARDS before enrolment Mean duration Details of prone positioning Criteria for discontinuation Protective lung ventilation mandated Guérin et al., Taccone et al., Fernandez et al., Variable Mandated Not mandated Duration of prone positioning 16 h/d < 16 h/d Level of hypoxemia* Severe Moderate Mild 474 ARDS with PaO2/FIO2 ratio < 150 mm Hg, PEEP 5 cm H2O and FIO2 60% after stabilization period of h Deaths, n/n 154/ / / /403 75/210 75/274 3/ < 36 h 17 h daily for 4 d PaO2/FIO2 ratio 150 mm Hg, PEEP 10 cm H2O and FIO ARDS with PEEP 5 cm H2O < 72 h 18 h daily for 8.3 d FIO2 40% and PEEP 10 cm H2O 42 ARDS < 48 No. of I 2 h 18 h daily PaO2/FIO2 ratio > 250 mm Hg value, Favours and PEEP Favours 8 cm H2O for trials Prone Supine RR (95% CI) % prone 12 h supine Chan et al., ARDS secondary to Protective lung ventilation community-acquired pneumonia Mancebo et al., Curley et al., Voggenreiter et al., Guérin et al., Beuret et al., Watanabe et al., Gattinoni et al., ARDS with infiltrates in 4 quadrants on chest 4 radiograph 102 children (age 2 wk 18 yr) < 72 h 24 h daily for 4.4 d SpO2 > 90%, FIO2 < 60% for > 24 h (after 72 h) 209/ / / / /268 3/ (CI ) 0.77(CI ) 1.02 (CI ) 0.76 (CI ) 0.74 (CI ) 0.98 (CI ) < 48 h 17 h daily for 10.1 d FIO2 45% and PEEP 205/ (CI ) 0 5 cm H2O RR (95% CI) p = 0.05 Acute lung injury or ARDS < 48 h 18 h daily for 4 d Spontaneous breathing and O2 index < 6 40 Acute lung injury (duration 24 h) or ARDS (duration 8 h) with PEEP 5 cm H2O 802 Hypoxemic acute respiratory failure (n = 413 with 6 acute lung injury or ARDS ) 53 Coma, intubation required (n = 7 with acute lung injury or ARDS ) 16 PaO2/FIO2 ratio < 200 mm Hg, PEEP > 5 cm H2O 5 d after esophagectomy 304 Acute lung injury or ARDS with PEEP 5 cm H2O p = < 48 h 11 h daily for 7 d PaO2/FIO2 ratio > 300 mm Hg for 48 h > h 9 h daily for 4.1 d Clinical improvement No 326 (238 in pts with acute lung injury or ARDS) Yes Yes Yes Yes No Yes Yes p > 0.9 NR NR < 24 h 4 h daily for 6.0 d Able to sit in chair No 166** NR NR Not prespecified 6 h daily for 4 d Not applicable No Not prespecified 7 h daily for 4.7 d None No Note: ARDS = acute respiratory distress syndrome, FIO2 = fractional concentration of inspired oxygen, NR = not reported, PaO2 = partial pressure of arterial oxygen, PEEP = positive end-expiratory pressure. *Additional details about the study characteristics are available in Appendix 3 ( Tidal volume < 8 ml/kg of predicted body weight. Defined according to the criteria of the American European Consensus Conference. 18 Average over first 2 d only; average number of days that prone positioning was used was not available. Defined by 1 major criterion (improvement in PaO2/FIO2 ratio 30% relative to value at randomization, with FIO2 60%) and at least 1 minor criterion (PEEP 8 cm H2O, no sepsis, cause of acute respiratory failure under control [stable or signs of improvement on chest radiograph, and < 3 organ dysfunctions, including lung dysfunction]). **Prone group only (baseline ratio in supine group not reported).

9 RATIONALE Since summer of 2013 proning has become more common in our ICUs Although best clinical judgment to follow the PROSEVA trial s protocol as a guideline are used, there remains inconsistency in the timing and duration of proning in our ARDS patients.

10 PROJECT GOAL Introduce and implement an evidence-based clinical decision tool for implementing proning in ARDS Including rationale for each decision made Criteria What are the indications and contraindications to Proning? Timing When to start and stop? Implementation

11 UPDATE

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13 FEEDBACK Big Project KISS!!

14 Criteria What are the indications and contraindications to Proning? Timing When to start and stop? Implementation

15 CRITERIA Indications (need all!) 1. Confirmed ARDS 36hrs hrs of Ventilator Optimization 3. PaO 2 /FiO PEEP 10cmH 2 O or 14cmH 2 O 5. Central Line Access 6. Functioning Arterial Line (if not, consider brachial) FiO 2 Criteria? PROSEVA added FiO More on this later.

16 CRITERIA PaO 2 /FiO PEEP 10cmH 2 O Table 1: Characteristics of randomized controlled trials included in the systematic review* Patient characteristics at baseline Study No. of patients Enrolment criteria Mean PaO2/FIO2 ratio, mm Hg Mean PEEP, cm H2O Mean FIO2, % Duration of ARDS before enrolment Guérin et al., Taccone et al., Fernandez et al., ARDS with PaO2/FIO2 ratio < 150 mm Hg, PEEP 5 cm H2O and FIO2 60% after stabilization period of h < 36 h 344 ARDS with PEEP 5 cm H2O < 72 h 42 ARDS < 48 h Chan et al., ARDS secondary to community-acquired pneumonia < 72 h Mancebo et al., ARDS with infiltrates in 4 quadrants on chest radiograph < 48 h Curley et al., children Acute lung injury or ARDS < 48 h

17 CONTRAINDICATIONS ABSOLUTE Contraindications Ongoing hemodynamic instability despite vasopressors (5 Trials) Elevated Intracranial Pressure (6 Trials) Unstable Fractures (Spine, long-bone, Pelvis) (6 Trials) Pregnancy (2 nd or 3 rd Trimester) (2 Trials) Relative Contraindications Massive haemoptysis needing urgent treatment (2 Trials) Tracheal or thoracic surgery in the last 15 days (2 Trials) Facial trauma or surgery in the last 15 days (1 Trial) DVT or PE treated in the last 2 days (2 Trials) Cardiac pace maker implantation in the last 2 days (2 Trials) Bronchopleural fistula treated with a single anterior chest tube (risk of kinking in prone position) (2 Trials)

18 TIMING 1. Key Differences in ARDS protocols in studies and current LHSC routine practice 1. Criteria to Start and Stop PEEP Tables 2. May require a general consensus on how we treat ARDS in LHSC 3. Streamline timing of when patients are Supine

19 HIGH PEEP VERSUS LOW PEEP ALL major trials investigating proning to date have used the classic ARDSnet PEEP table FiO PEEP LHSC has adopted high-peep LOVS-protocol ventilation strategy for managing ARDS patients FiO PEEP Is there a role for high-peep ventilation in the prone patient?

20 LOVS TRIAL Variables Lung Open Ventilation Day 1 Day 3 Day 7 Control P Value Lung Open Ventilation Control PaO 2 /FIO 2,mean(SD) 187.4(68.8) 149.1(60.6) (60.6) (63.5) (70.5) (73.0).001 No. of patients PaO 2,mean(SD),mmHg 88.1(32.0) 80.1(25.2) (14.8) 76.4 (16.2) (15.6) 77.0 (17.1).56 No. of patients FIO Pa 2,mean(SD),mmHg 0.50(0.16) 45.5(12.0) 0.58(0.17) 44.6(10.9) (9.5) (0.12) (9.8) (0.16) (10.3) (0.12) (11.7) (0.17) P Value Lung Open Ventilation No. of patients Control P Value Table 6. Outcomes a No. (%) Outcomes Lung Open Ventilation (n = 475) Control Ventilation (n = 508) Relative Risk (95% Confidence Interval) P Value Death in hospital 173 (36.4) 205 (40.4) 0.90 ( ).19 Death in intensive care unit 145 (30.5) 178 (35.0) 0.87 ( ).13 Death during mechanical ventilation 136 (28.6) 168 (33.1) 0.87 ( ).13 Death during first 28 d 135 (28.4) 164 (32.3) 0.88 ( ).20 Barotrauma b 53 (11.2) 47 (9.1) 1.21 ( ).33 Refractory hypoxemia 22 (4.6) 52 (10.2) 0.54 ( ).01 Death with refractory hypoxemia 20 (4.2) 45 (8.9) 0.56 ( ).03 Refractory acidosis 29 (6.1) 42 (8.3) 0.81 ( ).39

21 446 Cornejo, Dı az, Tobar, et al.: Prone Decreases Instability and Hyperinflation AMERICAN JOURNAL OF RESPIRATO 445 HIGH PEEP VS LOW PEEP Effects of Prone Positioning on Lung Protection in Patients with Acute Respiratory Distress Syndrome Fig bre lun Figure 3. EffectsA. of positive pressure (PEEP) 3, Cristobal Rodrigo A. Cornejo1, Juan C. Dı az2, Eduardo A. Tobar1, Alejandro R. Bruhn Ramos2end-expiratory, pre and prone positioning on cyclic recruitment/derecruit Roberto A. Gonza lez, Claudia A. Repetto, Carlos M. Romero, Luis R. Ga lvez, Osvaldo Llanos, fou ment and tidal hyperinflation 1, (R/D) Daniel H. Arellano1, Wilson R. Neira1, Gonzalo A. Dı az1, Anı bal J. Zamorano and Gonzalo L. Pereira2 (TH). Cyclic R/D and (lo TH with PEEP 5 and 15 cm H2O, assessed in supine (supine 1 2 and supine 15) and positioning Unidad de Pacientes Crı ticos, Departamento de Medicina, Hospital Clı nico Universidad de5chile; Departamento deprone Radiologı a, Hospital(prone Clı nico 5 and wa Universidad de Chile, Santiago, Chile; and 3Departamento de Medicina Intensiva, Facultad prone de Medicina, Pontificia Universidad de Chile, 15). Data are presented forcato lica the overall population wh Santiago, Chile (n ¼ 24) (A), for the subgroup of patients with high lung sur recruitability (n ¼ 14) (B), and for the subgroup of patients of with low lung recruitability (n ¼ 10) (C). *P, 0.05 berationale: Positive end-expiratory pressure (PEEP) and prone positween parameters at supine 5 and prone 15 cm H2O. ypin, tioning may induce lung recruitment and affect alveolar dynamics in AT A GLANCE 0.05 COMMENTARY between parameters at supine 5 and supine 15 cm ten acute respiratory distress syndrome (ARDS). Whether there is interbetween parameters at supine 15 and H2O. zp,on0.05 Scientific Knowledge the Subject dependence between the effects of PEEP and prone positioning on pro prone 15 cm H2O. these variables is unknown. Experimental and clinical studies suggest that high levels of ab Objectives: To determine the effects of high PEEP and prone posipositive end-expiratory pressure (PEEP) and prone positioning on lung recruitment, cyclic recruitment/derecruitment, pa tioning may favor protective mechanical ventilation in and tidal hyperinflation and how these effects are influenced by patients with acute respiratory distress syndrome. High wa lung recruitability. Methods: Mechanically ventilated patients (VT 6 ml/kg ideal body weight) underwent whole-lung computed tomography (CT) during breath-holding sessions at airway pressures of 5, 15, and 45 cm H2O and Cine-CTs on a fixed thoracic transverse slice at PEEP 5 and 15 cm H2O. CT images were repeated in supine and prone positioning. A recruitment maneuver at 45 cm H2O was performed before each PEEP change. Lung recruitability was defined as the difference in percentage of nonaerated tissue between 5 and 45 cm H2O. Cyclic PEEP may induce lung recruitment and decrease cyclic recruitment/derecruitment; however, increasing PEEP may increase hyperinflation. Prone positioning could have synergistic effects with high PEEP by providing a more uniform recruitment and better distribution of lung stress. What This Study Adds to the Field In ventilated patients with acute respiratory distress syn-

22 HIGH PEEP VERSUS LOW PEEP To date, no clinical protocol has been used in any published trial combining HIGH PEEP and Prone Positioning Three possible solutions

23 SOLUTION 1 LHSC stops using HIGH PEEP protocol in favor of Classic ARDSnet PEEP table Use PaO 2 /FiO with PEEP 10 as targets for flipping Benefits Already using this PEEP table for routine ventilation Maximize evidence-based benefits of Prone by using PROSEVA protocol Risks Physician and RT education regarding change ventilation strategy Theoretical risk of increased refractory hypoxia and death secondary to refractory hypoxia

24 SOLUTION 2 Combine HIGH PEEP and PRONING Strategies Use PaO 2 /FiO with PEEP 14 as targets for flipping BENEFITS Theoretical benefit combining strategies (small study) Can follow current LHSC best practice ARDS strategy RISKS Unproven No direct evidence for combined strategy

25 SOLUTION 3 Do BOTH!! Implement one strategy at each site as part of a PILOT study for a future RCT

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27 OUTSTANDING ISSUES 1. Decision about which ventilation strategy LHSC will follow 2. Implement protocol 1. Laminated protocol sheets, HUGO check box 2. Academic Half-day Fellow Education 3. RT Education 4. Nursing Education about protocol existence 3. Test implementation 1. Compare pre- and post- LHSC wide versus Site specific comparison (CCTC vs MSICU) 1. Outcome measures: Prone time, Sedation requirements, NMB requirements, Ventilator time

28 THOUGHTS?? Thank You