Skip to main content
Clinical Trials/NCT01289600
NCT01289600
Completed
Not Applicable

The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)

University Medical Center Nijmegen1 site in 1 country12 target enrollmentJanuary 2011
ConditionsARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
University Medical Center Nijmegen
Enrollment
12
Locations
1
Primary Endpoint
Pressure-time product of the diaphragm
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
March 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University Medical Center Nijmegen
Responsible Party
Principal Investigator
Principal Investigator

Leo Heunks

MD PhD

University Medical Center Nijmegen

Eligibility Criteria

Inclusion Criteria

  • intubated, mechanically ventilated patients
  • meeting criteria for ARDS
  • mean arterial blood pressure \> 65 mmHg (with or w/o vasopressors)

Exclusion Criteria

  • pregnancy
  • increased intracranial pressure
  • contra-indication naso-gastric tube
  • diagnosed neuro-muscular disorder
  • recent (\<12 hours) use of muscle relaxants
  • exclusion from sedation interruption protocol as used in our institution
  • open chest or- abdomen
  • very high inspiratory flow rate during supported ventilation
  • inability to obtain informed consent

Outcomes

Primary Outcomes

Pressure-time product of the diaphragm

Time Frame: average of last 15 minutes of each study arm

The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.

Patient - ventilator asynchrony index

Time Frame: average of last 15 minutes of each study arm

Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.

Secondary Outcomes

  • Transpulmonary pressure(average of last 15 minutes of each study arm)
  • Transdiaphragmatic pressure(average of last 15 minutes of each study arm)
  • Oxygenation index(at the end of each study arm)
  • Dead space ventilation(average of last 15 minutes of each study arm)

Study Sites (1)

Loading locations...

Similar Trials