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
  Purpose

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.


Condition Intervention
Acute Respiratory Distress Syndrome
Device: Mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)

Resource links provided by NLM:


Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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.
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: 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.
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: Neurally adjusted ventilatory assist, titrated
Mechanical ventilator is set to NAVA for 30 min with PEEP titrated using the diaphragm EMG signal.
Device: Mechanical ventilation
The mechanical ventilator is set to different ventilation modes as described in the individual arms.
Other Name: Maquet Servo-i

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289600

Contacts
Contact: Leo Heunks, MD, PhD +31 24 3617273 L.Heunks@ic.umcn.nl

Locations
Netherlands
University Medical Center Nijmegen Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Leo Heunks, MD, PhD    +31 24 3617273    L.Heunks@ic.umcn.nl   
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
Principal Investigator: Leo Heunks, MD, PhD Radboud University Nijmegen Medical Center
  More Information

No publications provided

Responsible Party: Leo Heunks, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01289600     History of Changes
Other Study ID Numbers: ARDS1
Study First Received: January 27, 2011
Last Updated: February 2, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014