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Ultrasound of the diaphragm could help doctors set ventilators more precisely

NCT ID NCT07697703

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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.
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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study tests a new way to measure diaphragm activity using ultrasound in patients on a breathing machine (ventilator). The goal is to see if this measurement can help doctors identify when the lungs are not fully emptying and adjust ventilator pressure accordingly. The study involves 100 adults on pressure support ventilation who are at risk of breathing difficulties. Researchers will compare the ultrasound results with standard measurements to see if this non-invasive method works well.

What this could mean

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

Active substance
Short-term PEEP step trial and EDRC ultrasound assessment
What this could lead to
If successful, this could give doctors a non-invasive way to fine-tune ventilator settings for individual patients, potentially improving breathing support and reducing complications.
What could go wrong
This is an early physiological study with 100 participants, so results may not apply broadly. The new index needs validation before it can be used in routine care.

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

About 100 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 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.

Who is studied

The study population will consist of adult patients ($\\ge$ 18 years) admitted to the Intensive Care Unit (ICU) who are receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode. Participants will be recruited from the ICU at \[Insert Name of Hospital/Institution\]. The population is characterized by patients who are clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or are undergoing a spontaneous breathing trial (SBT) as part of the weaning process. All enrolled patients will have an indwelling esophageal balloon catheter placed for the measurement of esophageal pressure (Pes), which serves as the reference standard for respiratory mechanics. Patients will be screened for eligibility based on hemodynamic stability and the ability to tolerate the study procedures. Specific exclusion criteria include pregnancy, severe esophageal pathology, severe hypoxemia, and conditions precluding diaphragmatic ultrasound imaging (e.g., chest wall tra

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: * Age ≥ 18 years. Patients receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode. Clinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or experiencing difficult weaning from mechanical ventilation. Presence of an indwelling esophageal balloon catheter (for reference standard measurements). Provision of written informed consent from the patient or legally authorized representative. Exclusion Criteria: * Pregnancy or lactation. Known esophageal diseases (e.g., esophageal varices, strictures, recent esophageal surgery) or contraindications to esophageal catheter placement. Severe hemodynamic instability (e.g., requiring high-dose vasoactive support, uncontrolled arrhythmias). Severe hypoxemia (PaO2/FiO2 \< 100 mmHg) or severe hypercapnia with hemodynamic compromise at baseline. Conditions precluding ultrasound assessment of the diaphragm (e.g., extensive chest wall trauma, large pleural effusion, severe subcutaneous emphysema). Active spontaneous breathing with severe patient-ventilator asynchrony that cannot be stabilized during the trial. Anticipated extubation or withdrawal of life-sustaining treatment within the next 24 hours. Participation in another interventional clinical trial within the last 30 days.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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