Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG-SAFE)

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1 Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG-SAFE) John Laffey, Giacomo Bellani, Tai Pham, Eddy Fan, Antonio Pesenti on behalf of the LUNG SAFE Investigators

2 Study Goals Impact of severe acute respiratory failure in ICUs in winter months Burden of Severe Acute Respiratory Failure ARDS versus other causes Contribution of ARDS (based on Berlin definition) Mortality according to ARDS severity Natural history of ARDS (duration and evolution by severity) Therapeutic resource utilization (rescue therapies) Use of non-invasive ventilation in management of ARDS

3 Study Design Global study in both northern and southern hemispheres Target to enroll 500 participating ICUs Each ICU recruited patients for 4 consecutive winter weeks Northern Hemisphere February 1 st to March 31 st 2014 Southern Hemisphere: June 1 st to August 31 st 2014 Inclusion Criteria for Screening All patients >16 years admitted to ICUs Receiving invasive or non-invasive ventilation Expanded dataset in patients with Severe Acute Respiratory Failure P/F 300 mmhg CPAP or PEEP of 5 or greater

4 For participating ICU s: Form 1 Study Flowchart and ecrf ICU ADMISSION Patient receiving ventilatory assistance and PaO 2 /FiO 2 < 300 on PEEP 5 and CXR abn NO Daily evaluation Discharge ICU mortality YES Initial Data collection Daily* Data collection ICU Discharge ICU mortality *Days 1 to 7, 10, 14, 28. Hospital mortality

5 RESULTS

6 Northern Hemisphere 49 Countries with ICUs Registered 40 countries recruited patients 32 countries recruited > 25 patients

7 Global Participation 62 Countries with ICUs Registered 50 countries recruited patients (40/10) 38 countries recruited > 25 patients

8 Patients enrolled by Country [Countries with > 25 pts] % of all Patients UK USA FRANCE CHINA SPAIN ITALY JAPAN NETHERLANDS AUSTRALIA CANADA SWEDEN GERMANY IRELAND PORTUGAL INDIA ARGENTINA BELGIUM NEW ZEALAND SWITZERLAND SAUDI ARABIA MEXICO NORWAY ROMANIA CHILE GREECE SOUTH AFRICA DENMARK TURKEY IRAN PERU MOROCCO SERBIA TUNISIA ALBANIA URUGUAY COSTA RICA GUATEMALA Updated 26/10/2014

9 Patients enrolled by Country [Countries with > 25 pts] % of all Patients UK USA FRANCE CHINA SPAIN ITALY JAPAN NETHERLANDS AUSTRALIA CANADA SWEDEN GERMANY IRELAND PORTUGAL INDIA ARGENTINA BELGIUM NEW ZEALAND SWITZERLAND SAUDI ARABIA MEXICO NORWAY ROMANIA CHILE GREECE SOUTH AFRICA DENMARK TURKEY IRAN PERU MOROCCO SERBIA TUNISIA ALBANIA URUGUAY COSTA RICA GUATEMALA Updated 26/10/2014

10 Participating ICUs by Country ICUs that recruited patients to LUNG-SAFE Study UK Spain France USA China Italy Japan Argentina Australia India Portugal Mexico Sweden Brazil Canada Saudi Aarabia Ireland Germany Uruguay Netherlands Chile Belgium Costa Rica New Zealand Morocco Greece Turkey Tunisia Norway Romania Russian Peru Serbia Iran Guatemala Albania Peru Switzerland Colombia Costa Rica Ecuador Austria Czech Republic Malaysia Philippines Poland Brunei Denmark Latvia Lebanon South Africa Yemen Updated 26/10/2014

11 Patient Characteristics Analysis plan TABLE 1 All Patients enrolled in LUNG SAFE Number of patients Enrolled 12,044 Age (years) 62 ± 17 Male:Female Ratio 1.5 : 1 Patients with Severe Respiratory Failure 4,221 Patients with ARDS 2,579 Duration of ICU Stay (all enrolled patients) 5 [3; 10] Duration of mechanical ventilatory support 7 [3; 13] Overall Survival (%) 9,599/12,040 (79.7%)

12 ARDS Incidence and Risk Factors Mild Moderate Severe P value Patients with ARDS Percentage of ARDS population 41% 38% 21% Patient age [Median, IQR] 63 ± ± ± 17 < Risk Factors Pneumonia 59% 57% 62% 0.33 Systemic Sepsis 15% 17% 17% 0.49 Aspiration gastric contents 12% 14% 19% Non-cardiogenic shock 7% 8% 8% 0.13 Trauma 3% 5% 2% No risk Factor 11 % 7% 5.5% SOFA score on D1 8 ± 4 10 ± 4 11 ± 4 < Worst SOFA score 10 ± 4 12 ± 4 13 ± 4 < Worst non-pulmonary SOFA 7 ± 4 9 ± 4 9 ± 4 < score

13 ARDS Ventilator Management Mild Moderate Severe P value FiO ± ± ± 0.17 < Total Respiratory Rate 22 ± ± ± Vt (ml/kg IBW) on Day ± ± ± PEEP 7.5 ± ± ± 3.4 < P PLAT 21.5 ± ± ± 6.0 < Patients in whom P PLAT was measured 33.2% 46.7% 49.2% NIV Use (%) 324 (43%) 0 0

14 Arterial PCO % of ARDS patients PCO2 60 at Day 1

15 Arterial ph

16 VT versus Plateau Pressure

17 PEEP versus FiO

18 PEEP versus FiO2

19 PEEP versus P/F Ratio

20 Inspired O 2 versus Arterial PO

21 Time course of ARDS No ARDS Mild ARDS Moderate ARDS Severe ARDS No ARDS at D1 Mild at D1 Moderate at D1 Severe at D1

22 Use of Adjunctive Measures Percentage of Patients NO ADJUNCTIVE MEASURE Recruitment NMBA Steroids Prone ECMO <50 P/F Ratio

23 Adjunctive treatments

24 Breathing unassisted to Day 90

25 Survival in patients with P/F and

26 Survival in patients with P/F <100 38% Mortality 46% Mortality

27 ARDS Recognition ARDS definition: P/F ratio 300 Bilateral opacities on CXR PEEP or CPAP 5 cmh 2 0 Rule out cardiac origin Onset less than 1 week Mild Moderate Severe Day Recognition 413 (56%) 465 (69%) 307 (82%)

28 Conclusions Global picture of Severe Acute Respiratory Failure in the 21 st Century ARDS appears to be under-recognized ARDS appears to be under-treated Conventional ventilation Use of adjunctive measures Nor clear (yet) if under-recognition contributes to under-treatment Not clear if better recognition and treatment of ARDS would enhance outcome

29 Thank You Over 13,000 patients Over 1,000 LUNG SAFE Investigators in ICUs across the Globe 666 ICUs registered patients for LUNG SAFE 475 ICUs validated patients into the study National coordinators in over 50 countries LUNG SAFE Steering Group and Executive Committee ESICM

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