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Breathing machine may harm diaphragm: new study investigates

NCT ID NCT03108118

Knowledge-focused Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how breathing machines (mechanical ventilators) might injure the diaphragm, the main muscle used for breathing. Researchers will monitor 50 ICU patients over their first 7 days on the ventilator, measuring diaphragm activity and function. The goal is to understand why some patients develop diaphragm weakness and how to prevent it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors understand how to adjust ventilator settings to reduce diaphragm injury in critically ill patients.
What could go wrong
This is a small observational study with only 50 participants, so results may not apply to all patients. It does not test any treatment, so no direct benefit is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Jun 2013

Finished

Dec 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Critically ill patients who are receiving invasive mechanical ventilation for less than 36 hours.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute respiratory failure injury respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diaphragm injury Mechanical ventilation complication Respiratory insufficiency

Contacts and locations

Locations

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • University Health Network

    Toronto, Ontario, M5G 2N2, Canada

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