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临床试验/NCT07567768
NCT07567768尚未招募2 期

The Effect of Continuous vs Bolus Neuromuscular Blockade Regimens for Patients With Moderate to Severe Hypoxemic Respiratory Failure and ARDS (COBRA): A Pilot Randomized Controlled Trial

University of Calgary0 个研究点目标入组 100 人开始时间: 2027年1月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
100

研究概览

简要总结

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.

详细描述

Study Title: The Effect of Continuous vs Bolus Neuromuscular Blockade for Patients with Moderate to Severe HRF and ARDS: A Pilot Randomized Controlled Trial

Background:

Acute Respiratory Distress Syndrome (ARDS) affects ~10% of ICU patients and carries high morbidity and mortality. Neuromuscular blockade agents (NMBAs), especially cisatracurium, have historically been administered via continuous infusion to improve oxygenation and reduce ventilator-induced lung injury. However, recent evidence (e.g., ROSE trial) questions this approach, and emerging guidelines suggest intermittent bolus dosing may offer similar benefits with fewer adverse effects. There is a lack of direct comparative data, creating uncertainty in clinical practice.

Hypothesis & Objectives:

The study hypothesizes that a multicenter RCT comparing intermittent bolus vs continuous NMBA infusion in ARDS is feasible and that bolus dosing may show trends toward improved outcomes (e.g., ventilator-free days, fewer adverse events).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ken Kuljit Parhar, MD

Clinical Associate Professor

University of Calgary

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