1. Results reported from included studies.
Outcome | Zapol 1979* | Morris 1994*† | Peek 2009‡ | Bein 2013§ |
Intervention/Population | VA ECMO + ventilation/ARDS patients | VV ECCO2‐R + ventilation/ARDS patients | VV ECMO + ventilation/ARDS patients | AV ECCO2‐R + ventilation/ARDS patients |
All‐cause mortality (number (%)) Intervention group (IG) vs control group (CG) |
38 of 42 (91) vs 44 of 48 (92) | 14 of 21 (66) vs 11 of 19 (57) | 33 of 90 (37) vs 45 of 90 (50) | 7 of 40 (17.5) vs 6 of 39 (15.4) |
All‐cause mortality difference IG vs CG (RR, 95% CI) | RR 0.99, 95% CI 0.87 to 1.12 Not statistically significant |
RR 1.15, 95% CI 0.71 to 1.88 Not statistically significant |
RR 0.73, 95% CI 0.52 to 1.03 Not statistically significant |
RR 1.14, 95% CI 0.42 to 3.08 Not statistically significant |
Length of hospital stay (LOS) days (± SD)a IG vs CG |
Not reported | 26.9 (4.9) vs 28.8 (5.7) Not statistically significant |
35 (15.6 ‐74) vs 17 (4.8 ‐45.3)b | 46.7 (33) vs 35.1 (17) Not statistically significant |
Survival to discharge (number (%)) IG vs CG |
Not reported | 7 (33)c vs 8 (42)c Not statistically significant |
Not reported | 33 (82.5) vs 33 (84.6) Not statistically significant |
Disability as reported by study authors | Normal lung function: 7 of 8 (both groups) No limitations in daily activities for all survivors |
Not reported | No severe disabilityd at 6 months: IG: 57 of 90 (63%) CG: 41 of 87 (47%) Statistically significant‡ |
Not reported |
Adverse outcomes | IG and CG: septicaemia (20%), pneumothorax (45%) Not statistically significant IG: lower blood platelet and white blood cell concentration and greater blood/ plasma infusion reported with 1 to 2.5 liters Statistically significant |
Major complicationse IG = 34 vs CG = 16 Not statistically significant Non‐brain haemorrhage IG = 21 vs CG = 0 Statistically significant IG: transfusion exceeded 0.8 L/d in 10 patients and led to bypass disconnection in 7 patients |
IG = 2 vs CG = 0
|
IG = 3 (7.5%) vs CG =0
Transfusion of blood unitsf IG = 3.7 units vs CG = 1.5 Statistically significant |
ARDS = acute respiratory distress syndrome.
AV ECCO2‐R = arteriovenous extracorporeal membrane carbon dioxide removal.
VV ECCO2‐R = veno‐venous extracorporeal membrane carbon dioxide removal.
aSD = Standard deviation.
b LOS days (interquartile range (IQR)).
cSurvival at 30 days after randomization.
dSevere disability was determined by the first 2 items of the EQ‐5D survey (item Mobility = unable to walk around, in addition to item Personal Care = unable to wash or dress).
eCentral nervous system (CNS), peripheral vascular and other.
fRed blood cell units until day 10.
*The ECMO configuration and respirator settings in the ECMO group and/or the control group are outdated.
†The trial was stopped after 40 participants.
‡3 patients in the control group had unknown disability status. If the 3 patients were severely disabled, RR of the primary outcome (death or severe disability) was 0.67 (95% CI 0.48 to 0.94; P value 0.017); it was 0.72 (95% CI 0.51 to 1.01; P value 0.051) if they were not severely disabled. Only 68 (75%) of participants randomly assigned to the intervention group actually received ECMO.
§Feasability study that used pump‐free avECCO2‐R to achieve very low tidal volume (3 mL/kg) in established ARDS compared with standard mechanical ventilation (6 mg/kg).