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Partial Neuromuscular Blockade in Acute Hypoxemic Respiratory Failure

ConditionsRespiratory InsufficiencyNeuromuscular BlockadeMechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cisatracurium

    Drug

    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.

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Partial NMBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of patients achieving and maintaining targeted expiratory occlusion pressure (Pocc)

Time frame
Assessed for 48 hours after study intervention initiation

Secondary outcomes

1

Rates of serious adverse events

Time frame
Assessed for 48 hours after study intervention initiation
2

Paralysis Recall

Evaluted using the modified Brice questionnaire.

Time frame
Assessed after 48 hours of the study intervention, as soon as the patient is extubated and oriented.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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