Primary Research Question for the Full ULTIMATE Randomized Clinical Trial (RCT): What is the effect of ultra-protective ventilation facilitated by extracorporeal membrane oxygenation (ECMO) versus best current conventional ventilation (CV) on all-cause hospital mortality among patients with early moderate-severe acute respiratory distress syndrome (ARDS)? Secondary Research Questions: Among patients with early moderate-severe ARDS, what is the effect of ultra-protective ventilation versus CV on: (1) duration of mechanical ventilation; (2) duration of ICU and hospital stay; (3) organ dysfunction; (4) barotrauma; and (5) mortality at other time-points (ICU discharge, 28-day, 60-day)? The ULTIMATE Pilot Study: Before embarking on a definitive multinational trial to address the questions listed above, the ULTIMATE Pilot Study has these 3 specific feasibility objectives: 1. To assess adherence to our explicit mechanical ventilation protocols, with particular focus on delivered tidal volumes in both groups; 2. To estimate the rate of patient recruitment and understand barriers to recruitment; and 3. To measure and understand the reasons for crossovers or rescue by ECMO in the control group. In addition, we will monitor safety issues, recording serious adverse events in both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Venovenous ECMO
New York Presbyterian Hospital
New York, New York, United States
OHSU Hospital
Portland, Oregon, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Unity Health
Toronto, Ontario, Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
...and 1 more locations
Proportion of patients adhering to the study protocol
Adherence to our explicit ventilation protocols will be adequate if more than 80% of patients have fewer than 10% of monitored values as major protocol violations
Time frame: Through study completion, an average of 2 years
Proportion of patients crossing over to VV ECMO
The number of protocol withdrawals or off-protocol treatment with VV ECMO will be acceptable if fewer than 10% of patients crossover or receive VV ECMO, when not allowed by the protocol
Time frame: Through study completion, an average of 2 years
Number of patients recruited for the study
Patient accrual will be adequate if we recruit 72 patients from 12 sites over 1 year of enrolment
Time frame: Through study completion, an average of 2 years
Ventilator-free days
Duration of alive and free of invasive mechanical ventilation
Time frame: Up to 30 days
Length of stay
ICU and hospital length of stay in survivors and non-survivors
Time frame: Through study completion, an average of 2 years
Number of patients with non-pulmonary organ dysfunction
Using standard definitions
Time frame: Up to 30 days
Number of patients with barotrauma
New barotrauma
Time frame: Up to 30 days
Mortality
At ICU discharge and 30-days
Time frame: Through study completion, an average of 2 years
Health-related quality of life
Health-related quality of life (EQ-5D) via telephone
Time frame: At 6 months post-randomization
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