Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure

NCT04524585 | Recruiting

• 1 other identifier: 19-5975
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of patients achieving and maintaining targeted expiratory occlusion pressure (Pocc)

  Assessed for 48 hours after study intervention initiation

Secondary Outcomes (2)

• Rates of serious adverse events

  Assessed for 48 hours after study intervention initiation

• Paralysis Recall

  Assessed after 48 hours of the study intervention, as soon as the patient is extubated and oriented.

Study Arms (1)

Partial NMB

EXPERIMENTAL

Drug: Cisatracurium

Interventions

Cisatracurium DRUG

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.

Partial NMB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

cisatracurium

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ewan Goligher, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glauco M. Plens, MD, PhD

CONTACT

4373299590; glauco.plens@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 24, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-07

Locations

CA (1)