Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO
NCT ID: NCT04832789
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2021-06-30
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Best conventional ventilation
No interventions assigned to this group
Ultra-protective ventilation with ECMO
Venovenous ECMO
Venovenous ECMO
Interventions
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Venovenous ECMO
Venovenous ECMO
Eligibility Criteria
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Inclusion Criteria
2. Endotracheal mechanical ventilation for ≤ 5 days
3. 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
4. ARDS severity criterion - either 1 of:
1. PaO2/FiO2 ≤ 150 mm Hg, on PEEP ≥ 10 cm H2O and FiO2 ≥ 0.5
Exclusion Criteria
2. Chronic hypercapnic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
3. Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not CPAP
4. Actual body weight exceeding 1 kg per centimeter of height
5. Severe hypoxemia with PaO2/FiO2 \< 80 mmHg
6. Expected mechanical ventilation duration \< 48 hours
7. Treating team is in the process of moving to a palliative mode of care
8. Moribund patient not expected to survive 24 hours despite ongoing life-sustaining therapies
9. Confirmed diffuse alveolar hemorrhage from vasculitis
10. Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis)
11. Pregnancy - due to unknown effects of PaCO2 changes on placental blood flow
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
University of Toronto
OTHER
Responsible Party
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Eddy Fan
Associate Professor
Principal Investigators
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Niall Ferguson, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Eddy Fan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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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
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
TBA
Role: primary
Other Identifiers
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ULTIMATE
Identifier Type: -
Identifier Source: org_study_id
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