Recruiting

NMB with VV-ECMO

Sponsor:

University Health Network, Toronto

Code:

NCT04524585

Conditions

Respiratory Insufficiency

Neuromuscular Blockade

Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cisatracurium

Study Details

Brief 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

Study ID

NCT04524585

Start date

Oct 1, 2020

Status verified date

Jul, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients supported on invasive mechanical ventilation for moderate to severe AHRF (PaO2/FiO2 < 150 mm Hg or FiO2 ≥ 60% with an SpO2 ≤ 97% or receiving venovenous extracorporeal membrane oxygenation)

Exclusion Criteria:

1. Contraindication to neuromuscular blockade (allergy, history of malignant hyperthermia)
2. Contraindication to ulnar nerve stimulation (bilateral peripheral neuropathy, skin burns on both wrists)
3. Previous history of a formally diagnosed neuromuscular disorder

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Partial NMB

Interventions

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.

Primary outcome measure

  • Rate of patients achieving and maintaining targeted expiratory occlusion pressure (Pocc) [ Time Frame: Assessed for 48 hours after study intervention initiation ]

Central Contacts and Locations

Central contacts

Glauco M. Plens, MD, PhD

4373299590glauco.plens@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Glauco Plens, MD PhD

glauco.plens@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 6, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-01-06.