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Completed

NCT Number: NCT01289600

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

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.

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Key information

Conditions

ARDS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Nijmegen

Nijmegen, Gelderland, 6525 GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

Device

The mechanical ventilator is set to different ventilation modes as described in the individual arms.

Other names: Maquet Servo-i

Primary outcomes

  1. 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.

  2. 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

  1. Transpulmonary pressure

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

    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.

  2. Transdiaphragmatic pressure

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

    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.

  3. Oxygenation index

    Time frame: at the end of each study arm

    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.

  4. Dead space ventilation

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

    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.

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2011
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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