Combes et al.(11 Combes A, Hajage D, Capellier G, Demoule A, Lavoue´ S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal membrane oxygenation for severe acute respiratory distress syndrome. N Engl J Med. 2018;378(21):1965-75.)
|
249 |
International multicenter, randomized, controlled clinical trial |
1. Patient intubated on MV < 7 days 2. PaO2/FiO2 < 50mmHg for > 3 hours OR PaO2/FiO2 < 80mmHg for > 6 hours OR Arterial pH < 7.25 with PaCO2 ≥ 60mmHg > 6 hours 3. Optimized MV
4. Age >18 years |
1. Pregnant women 2. BMI > 45 3. Chronic respiratory failure 4. Indication for VA-ECMO 5. History of HIT 6. Advanced cancer 7. Dying patients 8. Coma after cardiac arrest 9. Nonreversible neurologic injury 10. Palliative patients |
60-day mortality of 35% (44/124 patients) in the ECMO group and 46% (57/125 patients) in the control group (RR: 0.76; 95%CI 0.55 -1.04; p = 0.09) |
The ECMO group had a higher incidence of severe thrombocytopenia and bleeding requiring transfusion. The ECMO group had a lower incidence of IS, lower need for renal replacement therapy, and reduction of tidal volume, plateau pressure and drive pressure |
Early interruption of the study due to futility Slow recruitment rate High crossover rate (28%) from the control group to the ECMO group due to refractory hypoxemia Greater failure of treatment at 60 days in the control group |
Peek et al.(22 Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trialcollaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009;374(9698):1351-63. Erratum in Lancet. 2009;374(9698):1330.)
|
180 |
Multicenter, randomized, controlled clinical trial |
1. Age from 18 - 65 years 2. Severe but potentially reversible respiratory failure 3. Murray score ≥ 3.0 4. Uncompensated hypercapnia 5. Optimized MV |
1. PIP > 30cmH2O 2. FiO2 > 80% 3. Time of MV ≥ 7 days 4. Intracranial bleeding 5. Contraindication to heparinization 6. Limitation of support |
6-month mortality after randomization or before hospital discharge of 37% (33/90) in the ECMO group and 53% (46/87) in the control group (RR: 0.69; 95%CI 0.05-0.97, p = 0.03) |
The transfer of patients with severe but potentially reversible respiratory failure to a reference center in ECMO proved to be cost-effective and reduce mortality |
Control group does not have standardization of MV parameters Of the 90 patients randomized to receive ECMO, 22 patients did not use the device |
Morris et al.(33 Morris AH, Wallace CJ, Menlove RL, Clemmer TP, Orme JF Jr, Weaver LK, et al. Randomized clinical trial of pressure-controlled inverse ratio ventilation and extracorporeal CO2 removal for adult respiratory distress syndrome. Am J Respir Crit Care Med. 1994;149(2 Pt 1):295-305. Erratum in: Am J Respir Crit Care Med 1994;149(3 Pt 1):838.)
|
40 |
Dual-center, randomized, controlled clinical trial |
1. PaO2 < 50mmHg for 2 hours with FiO2 = 100%, PEEP > 5 and PaCO2 of 30 - 45 or PaO2 < 50mmHg for 12 hours with FiO2 = 60%, PEEP ≥ 5cmH2O and PaCO2 of 30 - 45 2. Optimized MV |
1. Contraindication to anticoagulants 2. POAP > 25mmHg 3. Time of MV> 21 days 4. Severe, irreversible and without treatment prospective systemic disease. |
30-day survival of 33% (7/21) in the ECMO group and 42% (8/19) in the control group (p = 0.8) |
Does not recommend the use of ECMO in patients with ARDS |
Small sample size High mortality rate (62% of patients died) Technical limitations inherent to the clinical trial period Nonprotective MV in both groups |
Zapol et al.(44 Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, et al. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979;242(20):2193-6.)
|
90 |
Multicenter, randomized, controlled clinical trial |
1. PaO2 < 50 mm Hg, for more than 2 hours with FiO2 100% and PEEP ≥ 5cmH2O OR PaO2 < 50 mm Hg, for more than 12 hours with FiO2 = 60% and PEEP ≥ 5cmH2O |
1. Age from 12 to 65 years old 2. Pulmonary lesion time > 21 days 3. PWP > 25mmHg 4. Severe, irreversible and incurable systemic disease. |
30-day survival of 9.5% (4/42) in the ECMO group and 8.3% (4/48) in the control group (no significant difference) |
ECMO was able to provide respiratory support, but did not increase the survival in patients with severe ARDS |
Mortality in both groups greater than 90% Technical limitations inherent to the clinical trial period Nonprotective MV in both groups |