Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Medical Center Nijmegen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01289600
First received: January 27, 2011
Last updated: February 2, 2011
Last verified: February 2011

January 27, 2011
February 2, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
  • Pressure-time product of the diaphragm [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01289600 on ClinicalTrials.gov Archive Site
  • Transpulmonary pressure [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]
    Transpulmonary pressure is determined as the difference between mouth pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
  • Transdiaphragmatic pressure [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]
    Transdiaphragmatic pressure is determined as the difference between gastric pressure and esophageal pressure during inspiration. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
  • Oxygenation index [ Time Frame: at the end of each study arm ] [ Designated as safety issue: No ]
    Oxygenation index is determined as the ratio between arterial oxygen tension and fraction of inspired oxygen. Arterial oxygen tension is obtained at the end of each study arm.
  • Dead space ventilation [ Time Frame: average of last 15 minutes of each study arm ] [ Designated as safety issue: No ]
    Dead space ventilation is determined each breath using the Bohr equation: (PaCO2-PeCO2/PaCO2)*Vt. Here Vt is tidal volume, PaCO2 is the partial pressure of carbon dioxide in the arterial blood, and PeCO2 is the end-tidal carbon dioxide tension in the expired air. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Same as current
Not Provided
Not Provided
 
Mechanical Ventilation and Respiratory Muscle Work of Breathing in Acute Respiratory Distress Syndrome (ARDS) Patients
The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Respiratory Distress Syndrome
Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i
  • Active Comparator: Pressure support ventilation, ARDSnet
    Mechanical ventilator is set to pressure support ventilation (6 ml/kg) for 30 min with positive end expiratory pressure (PEEP) set according to the "higher arm" of the ARDS network consensus.
    Intervention: Device: Mechanical ventilation
  • Active Comparator: Pressure control ventilation, ARDSnet
    Mechanical ventilator is set to pressure control ventilation (6 ml/kg) for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
    Intervention: Device: Mechanical ventilation
  • Active Comparator: Neurally adjusted ventilatory assist, ARDSnet
    Mechanical ventilator is set to NAVA for 30 min with PEEP set according to the "higher arm" of the ARDS network consensus.
    Intervention: Device: Mechanical ventilation
  • Active Comparator: Neurally adjusted ventilatory assist, titrated
    Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal.
    Intervention: Device: Mechanical ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Leo Heunks, MD, PhD +31 24 3617273 L.Heunks@ic.umcn.nl
Netherlands
 
NCT01289600
ARDS1
Yes
Leo Heunks, University Medical Center Nijmegen
University Medical Center Nijmegen
Not Provided
Principal Investigator: Leo Heunks, MD, PhD Radboud University Nijmegen Medical Center
University Medical Center Nijmegen
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP