Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure
NCT04524585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2026-01-06
Summary
PNEUMA is a preliminary safety and feasibility trial of a novel approach to the titration of neuromuscular blockade (NMB) to safe spontaneous breathing in patients with moderate to severe acute hypoxemic respiratory failure (AHRF) supported with invasive mechanical ventilation.
Conditions
- Respiratory Insufficiency
- Neuromuscular Blockade
- Mechanical Ventilation
Interventions
- DRUG
-
Cisatracurium
Cisatracurium will be infused to achieve Pocc targets after ensuring adequate sedation. Sedation will be titrated to avoid dyspnea, assessed with P0.1 targets between -1.5 and -3.5 cmH2O and Mechanical Ventilation Respiratory-Distress Observation Scale (MV-RDOS) ≤ 3. If there is no sign of dyspnea or discomfort based on P0.1, MV-RDOS, hemodynamics and the train-of-four ratio is ≥ 60% (compatible with ability to interact using peripheral muscles), sedation will be carefully reduced. After establishing a sedation and NMB strategy at which safe spontaneous breathing is achieved, we will seek to determine whether these targets can be maintained over a 48-hour period or until hypoxemia is resolved (FiO2 ≤ 40% on PEEP ≤ 8 cmH2O), whichever occurs first.
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Ewan Goligher, MD, PhD · University Health Network, Toronto
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-01
- Primary Completion
- 2026-12-01
- Completion
- 2027-03-01
Countries
- Canada
Study Locations
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