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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neuromuscular Blocking Agent - Bolus Dosing

    Drug

    Intermittent administration of NMBA

  • Neuromuscular Blocking Agent - Continuous Infusion

    Drug

    Continuous infusion of NMBA

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Bolus DosingExperimental treatment 1 intervention
Group B: Continuous InfusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate among eligible patients

Recruitment rate among eligible patients

Time frame
Within 48 hours of meeting ARDS criteria
2

Protocol adherence rate

Protocol adherence rate

Time frame
for the first 28 days of mechanical ventilation
3

Proportion of missing baseline characteristics and outcomes

Proportion of baseline characteristics and outcomes that are missing

Time frame
First 28 days of invasive ventilation post ARDS diagnosis.
4

Compositive Safety

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

Time frame
First 28 days of invasive ventilation post ARDS diagnosis.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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