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Completed

NCT Number: NCT03108118

Diaphragm Injury and Dysfunction During Mechanical Ventilation

This study is designed to evaluate the relationship between diaphragm activity during mechanical ventilation and the development of ventilator-induced diaphragm dysfunction (VIDD). Diaphragm structure, activity, and function are monitored longitudinally over the first 7 days of mechanical ventilation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

Multiple factors are responsible for injury to the diaphragm during mechanical ventilation and critical illness. Suppression of respiratory drive and respiratory muscle activity can contribute to diaphragm dysfunction and increase the risk of prolonged mechanical ventilation.

The objective of this study is to determine whether diaphragm inactivity or injurious loading of hte diaphragm during mechanical ventilation leads to the development of diaphragm weakness. To address this question, we are monitoring the diaphragm longitudinally over the first week of mechanical ventilation.

Diaphragm activity is monitored by measurements of transdiaphragmatic pressure and diaphragm electrical activity. Diaphragm function is assessed by maximal transdiaphragmatic pressure generation and by measurements of diaphragm neuromuscular coupling. Diaphragm structure is assessed by daily ultrasound imaging.

Study measurments commence at enrolment (within 36 hours of intubation) and continue for the first 7 days of the study (or until extubation or death, if earlier).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (>18) with acute respiratory failure receiving invasive mechanical ventilation for less than 36 hours diagnosed with any of the following conditions: acute severe brain injury; moderate or severe ARDS; septic shock; pneumonia

Exclusion criteria

  • Predicted probability of remaining alive and on the ventilator on ICU day 7 is less than 50%
  • Liberation from mechanical ventilation is expected/planned within 24 hours
  • High cervical spine injury (C5 or higher)
  • Receiving mechanical ventilation for neuromuscular disease
  • Acute exacerbation of an obstructive lung disease
  • Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
  • Esophageal, gastric or duodenal surgical procedures within the last 6 months
  • Received mechanical ventilation for > 48 hours in the preceding 6 months

Treatment and study plan

Primary outcomes

  1. Diaphragm dysfunction

    Time frame: 7 days

    Diaphragm dysfunction will be defined as maximal transdiaphragmatic pressure < 30 cm H2O and/or maximal diaphragm thickening fraction < 20% at study completion

Secondary outcomes

  1. Diaphragm thickness

    Time frame: 7 days

  2. Diaphragm neuromuscular coupling

    Time frame: 7 days

  3. Duration of inactivity (hours)

    Time frame: 7 days

  4. Patient-ventilator asynchrony rate

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: MYOTRAUMA

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2017
Registry last updated
Jun 23, 2026

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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