ow dose muscle relaxans to improve mechanical ventilatio

Phase 1

• Conditions: Some patients develop high respiratory drive during partially supported mechanical ventilation which is associated with lung and diaphragm injury and worse clinical outcome; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-000748-24-NL
• Lead Sponsor: VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-27
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients are eligible for inclusion if they meet all of the following
criteria:
- high respiratory drive, defined as tidal volume > 8ml/kg PBW on
inspiratory support of 12cmH2O.
- sedation level: RASS = -3
- ventilated in pressure support mode
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

A potential subject who meets any of the following criteria will be
excluded from participation in this study:
- 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
- pregnancy
- known previous anaphylactic reaction to NMBA's.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified