Partial Neuromuscular Blockade for Lung Protective Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2020-12-31

Brief Summary

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Controlled mechanical ventilation may lead to the development of diaphragm muscle atrophy, which is associated with weakness and adverse clinical outcome. Therefore, it seems reasonable to switch to partially supported ventilator modes as soon as possible. However, in patients with high respiratory drive, the application of partially supported modes may result in high lung distending pressures and diaphragm injury.

Recently, the investigators published a study that demonstrated that a low dose of neuromuscular blocking agents (NMBA) facilitates lung-protective ventilation and maintains diaphragm activity in intensive care unit (ICU) patients. That study was conducted in a small (N=10), selected group of patients and partial neuromuscular blockade was applied for only 2 hours (proof-of-concept study). Therefore, further research has to be done before this strategy can be applied in clinical practice.

The primary goal is to investigate the feasibility and safety of prolonged (24 hours) partial neuromuscular blockade in patients with high respiratory drive in partially supported mode. The secondary goals are to evaluate the effect of this strategy diaphragm function, lung injury, hemodynamics and systemic inflammation.

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Detailed Description

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Conditions

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Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pilot randomized controlled trial (RCT)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rocuronium

Titration of rocuronium bromide until tidal volume of 6ml/kg predicted body weight (PBW) is reached

Group Type EXPERIMENTAL

Rocuronium Bromide

Intervention Type DRUG

Titration with rocuronium bromide until tidal volume 6ml/kg PBW

Control

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rocuronium Bromide

Titration with rocuronium bromide until tidal volume 6ml/kg PBW

Intervention Type DRUG

Other Intervention Names

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Esmeron

Eligibility Criteria

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Inclusion Criteria

* high respiratory drive, defined as tidal volume \> 8ml/kg PBW on inspiratory support of 12 cmH2O.
* sedation level: richmond agitation-sedation scale (RASS) ≤ -3
* ventilated in pressure support mode

Exclusion Criteria

* recent use of NMBA (\< 2 hrs)
* arterial pH \< 7.25
* hemodynamic instability, i.e. high dose vasopressors (\>0.5 μg/kg/min) or inotropes (dobutamine \>15 μg/kg/min or enoximone \>25 μg/kg/min)
* intracranial pressure \> 20 cmH2O
* past medical history of neuromuscular disorders
* known pregnancy
* known previous anaphylactic reaction to NMBA's.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No