Status:
UNKNOWN
Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
ARDS
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 bes...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Endotracheal mechanical ventilation for ≤ 5 days
- Early moderate-severe ARDS (Berlin Definition) - all of the following conditions for ≤ 48 hours i. PaO2/FiO2 ≤200 with PEEP \> 5 cmH2O ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload iv. within one week of a known insult of new or worsening respiratory symptoms
- ARDS severity criterion - either 1 of:
- PaO2/FiO2 ≤ 150 mm Hg, on PEEP ≥ 10 cm H2O and FiO2 ≥ 0.5
Exclusion
- Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
- Chronic hypercapnic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not CPAP
- Actual body weight exceeding 1 kg per centimeter of height
- Severe hypoxemia with PaO2/FiO2 \< 80 mmHg
- Expected mechanical ventilation duration \< 48 hours
- Treating team is in the process of moving to a palliative mode of care
- Moribund patient not expected to survive 24 hours despite ongoing life-sustaining therapies
- Confirmed diffuse alveolar hemorrhage from vasculitis
- Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis)
- Pregnancy - due to unknown effects of PaCO2 changes on placental blood flow
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04832789
Start Date
June 1 2021
End Date
December 1 2023
Last Update
April 6 2021
Active Locations (11)
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1
New York Presbyterian Hospital
New York, New York, United States, 10032
2
OHSU Hospital
Portland, Oregon, United States, 97239
3
University of Alberta Hospital
Edmonton, Alberta, Canada
4
London Health Sciences Centre
London, Ontario, Canada