Continuous vs Bolus Neuromuscular Blockade Regimens in Moderate to Severe Hypoxemic Respiratory Failure and ARDS (COBRA)

NCT07567768 | Not Yet Recruiting Phase 2

• 1 other identifier: REB25-1049
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Current clinical guidelines, such as those from the Surviving Sepsis Campaign and ARDSNet, recommend short-term NMBA use for patients with moderate to severe ARDS who exhibit persistent ventilator dyssynchrony or high plateau pressures despite deep sedation . However, they do not provide clear recommendations regarding the mode of administration. As a result, clinicians are left to extrapolate from limited or indirect evidence, which may lead to practice variation, uncertainty, and suboptimal care. This pilot randomized controlled trial is designed to directly address this critical gap by comparing intermittent bolus administration versus continuous infusion of NMBAs in a pragmatic, real-world ICU setting. The study will assess feasibility metrics necessary to plan a definitive trial and generate preliminary clinical data on safety and effectiveness. By clarifying the comparative benefits and risks of each approach, the results may influence practice guidelines, reduce variation in care, and improve patient outcomes and reduce practice variation.patient outcomes, optimize resource use, and inform future guidelines on the management of moderate to severe ARDS.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

ARDS; Neuromuscular Blockade; mechanical ventilation

Outcome Measures

Primary Outcomes (4)

• Recruitment rate among eligible patients

  Recruitment rate among eligible patients

  Within 48 hours of meeting ARDS criteria

• Protocol adherence rate

  Protocol adherence rate

  for the first 28 days of mechanical ventilation

• Proportion of missing baseline characteristics and outcomes

  Proportion of baseline characteristics and outcomes that are missing

  First 28 days of invasive ventilation post ARDS diagnosis.

• Compositive Safety

  rates of ICU acquired weakness, unplanned extubation, and other SAE

  First 28 days of invasive ventilation post ARDS diagnosis.

Study Arms (2)

Bolus Dosing

EXPERIMENTAL

Bolus dosing

Drug: Neuromuscular Blocking Agent

Continuous Infusion

ACTIVE COMPARATOR

Continuous Infusion

Drug: Neuromuscular Blocking Agent

Interventions

Neuromuscular Blocking Agent DRUG

Bolus dosing

Bolus Dosing; Continuous Infusion

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Mechanically ventilated and on a controlled ventilation mode
• Diagnosis of moderate to severe ARDS (PaO₂/FiO₂ ≤150 mmHg on PEEP ≥5 cm H₂O)
• Bilateral pulmonary infiltrates consistent with ARDS
• Randomized within 24 hours of meeting ARDS criteria

You may not qualify if:

• Pregnancy
• Known allergy or contraindication to rocuronium
• Neuromuscular disorders (e.g., myasthenia gravis, Guillain-Barré syndrome)
• Brain death or decision for withdrawal of life-sustaining therapy
• Enrollment in a conflicting interventional trial

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Neuromuscular Blocking Agents

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Ken Parhar, MD MSc MPH

CONTACT

000-000-0000; ken.parhar@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: May 5, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04