Partial neuromuscular blockade to enable safe spontaneous breathing in acute hypoxemic respiratory failure
Official title: Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure
Run by University Health Network, Toronto · NCT04524585 · Data updated 2026-11-12
This tests whether a low-dose infusion of the muscle-paralyzing drug cisatracurium can let people with moderate to severe low-oxygen respiratory failure on mechanical ventilation or venovenous ECMO breathe safely on their own while protecting their lungs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 23 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | October 1, 2020 |
| Main results expected | December 1, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT04524585 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with moderate to severe acute hypoxemic respiratory failure supported on invasive mechanical ventilation or venovenous-ECMO (PaO2/FiO2 <150 or FiO2 ≥60% with SpO2 ≤97%) who have no contraindication to neuromuscular blockade or ulnar nerve stimulation and no known neuromuscular disorder.
✕Probably not a fit
Patients with contraindications to neuromuscular blockers (for example allergy or malignant hyperthermia), bilateral ulnar neuropathy or wrist burns, or pre-existing neuromuscular disorders are not eligible and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PNEUMA is a preliminary safety and feasibility effort that uses a titrated infusion of cisatracurium to achieve partial neuromuscular blockade permitting controlled spontaneous breathing in patients with moderate to severe acute hypoxemic respiratory failure. After ensuring adequate sedation, investigators adjust the drug infusion to target an expiratory occlusion pressure (Pocc) between −5 and −15 cmH2O, a range intended to preserve moderate inspiratory effort while avoiding injurious efforts. Once targets are achieved, the protocol documents whether those sedation and dosing targets can be maintained over a 48-hour period. Eligibility was broadened from ARDS on ECMO to patients with AHRF supported with invasive mechanical ventilation or venovenous-ECMO at the enrolling center.
Why it matters
Potential benefit: If successful, this approach could reduce complications of full paralysis while keeping lung-protective ventilation and allowing some patient-initiated breathing.
How similar studies have gone: Full neuromuscular blockade has been used in ARDS, but partial neuromuscular blockade is a relatively novel approach with limited prior clinical trial data on safety and efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Health Network
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Ewan Goligher, MD, PhD — University Health Network, Toronto
- Study coordinator: Glauco M. Plens, MD, PhD
- Email: glauco.plens@uhn.ca
- Phone: 4373299590
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
NMTCuff vs standard TOF monitoring during gynecologic oncology surgery
This study tests whether NMTCuff monitoring can better detect neuromuscular recovery than standard TOF monitoring in women undergoing laparoscopic gynecologic cancer surgery.
-
Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS
This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.
-
Computed inspiratory muscle pressure to monitor inspiratory effort during pressure-targeted assist/control ventilation
This study tests a noninvasive computed pressure method (cPmus) to see if it matches the traditional esophageal pressure method for measuring inspiratory effort in adults on pressure-targeted ventilation with spontaneous breathing.
-
Noninvasive estimate of inspiratory effort to monitor pressure support ventilation
This study tests whether a noninvasive computed inspiratory muscle pressure (cPmus) can match the traditional esophageal pressure method for adults on pressure support ventilation.
-
Driving pressure-guided individualized PEEP vs standard PEEP during upper abdominal surgery
In this randomized trial, adults at higher risk of breathing problems after upper abdominal surgery will try a personalized PEEP level based on the lowest driving pressure and compare it to a fixed PEEP of 5 cmH2O to see if it lowers postoperative lung complications.
-
Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults
This study tests how different patient breathing efforts relate to breathlessness in adults on assisted mechanical ventilation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.