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Tweaking ventilator settings could ease breathlessness and cut PTSD risk in ICU survivors

NCT ID NCT07701850

Knowledge-focused Sponsor: Beth Israel Deaconess Medical Center 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This pilot study investigates how standard changes to mechanical ventilator settings—such as breath size, flow rate, and pressure—affect shortness of breath in awake patients on ventilators. Many ICU patients experience breathlessness despite sedation, which may contribute to PTSD after recovery. By testing safe adjustments in 20 patients, researchers aim to identify settings that improve comfort and reduce long-term mental health problems.

What this could mean

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

Active substance
standard ventilator setting adjustments (tidal volume, flow, PEEP, mode changes)
What this could lead to
If successful, this study could point toward ventilator strategies that reduce shortness of breath and lower the risk of PTSD in survivors of severe respiratory failure.
What could go wrong
This is a very small pilot study (20 patients) that only measures short-term changes in dyspnea. Results may not apply to all ventilated patients or lead to clear clinical recommendations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

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.

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: * Admitted to a participating ICU at BIDMC * Requiring mechanical ventilation * Awake by both of the following criteria * RASS -2 to +2\* * CAM-ICU negative‡ * Able to communicate/answer dyspnea questionnaire * RASS (Richmond Agitation-Sedation Scale) is a validated scale commonly used in the ICU to assess patient's level of sedation and agitation. It ranges from -5 to +4. While -5 means an unarousable coma, +4 means violent patient with immediate self danger. The scale from -2 to +2 ranges from light sedation to agitated. * CAM-ICU (Confusion Assessment Method) is an ICU validated scale used to assess the presence of delirium. A negative CAM-ICU scale has good positive and negative predictive value to diagnose or exclude delirium. Physicians and nurses are trained to evaluate patients using both scales Exclusion Criteria: * Age \< 18 years old * Comfort measures only * Hemodynamic instability (MAP \< 65 mmHg) or increasing requirement of vasopressor * PEEP \> 10 cmH2O * FiO2 \> 0.6 * Current Prone position * Current Pneumothorax * Bronchopleural fistula * Neuromuscular conditions that impair responding to the dyspnea scale or expression * Dementia * Prisoners * Pregnant women * Patients intubated and ventilated for less than 12 hours during the current ventilation episode * pH \< 7.20 or \> 7.55 * Presence of chest tube * Status post thoracotomy * Treating clinician refusal

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Conditions

The condition(s) this trial relates to.

Dyspnea respiratory failure

As listed by the trial registrant

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

Dyspnea during mechanical ventilation Mechanical ventilation Respiratory failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

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