Trials / Unknown
UnknownNCT03646266
Partial Neuromuscular Blockade for Lung Protective Mechanical Ventilation
Partial Neuromuscular Blockade to Facilitate Lung and Diaphragm Protective Mechanical Ventilation in Intensive Care Unit Patients: a Randomized Controlled Pilot Study
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Amsterdam UMC, location VUmc · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rocuronium Bromide | Titration with rocuronium bromide until tidal volume 6ml/kg PBW |
Timeline
- Start date
- 2018-08-15
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2018-08-24
- Last updated
- 2020-05-20
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03646266. Inclusion in this directory is not an endorsement.