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Clinical Trials/EUCTR2018-000748-24-NL
EUCTR2018-000748-24-NL
Active, not recruiting
Phase 1

Partial neuromuscular blockade to facilitate lung and diaphragm protectivemechanical ventilation in ICU patients.A randomized controlled pilot study.

VUmc0 sites30 target enrollmentJune 27, 2018
DrugsEsmeron

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
VUmc
Enrollment
30
Status
Active, not recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 27, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
VUmc

Eligibility Criteria

Inclusion Criteria

  • Patients are eligible for inclusion if they meet all of the following
  • \- 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

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
  • \- intracranial pressure \> 20 cmH2O
  • \- past medical history of neuromuscular disorders
  • \- pregnancy
  • \- known previous anaphylactic reaction to NMBA's.

Outcomes

Primary Outcomes

Not specified

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