RecruitingNot ApplicableNCT04524585

Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure


Sponsor

University Health Network, Toronto

Enrollment

23 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria3

  • 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

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Interventions

DRUGCisatracurium

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.


Locations(1)

University Health Network

Toronto, Ontario, Canada

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NCT04524585


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