CompletedNot Applicable

Diaphragm Ultrasound Vs Transpulmonary Pressure To Set PEEP in ARDS

United States14 participantsStarted 2015-06

Plain-language summary

This is a proof of concept study where the investigators aim to study the correlation between the use of a simple bedside ultrasound measurement of diaphragmatic muscle excursion with established (but time consuming) measurements made to optimize an important setting on the mechanical ventilator (positive end expiratory pressure or PEEP) in intubated adults with acute respiratory distress syndrome (ARDS) in the medical ICU.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults older than 18 years old who develop ARDS, as defined by the Berlin criteria, within 72 hours of ICU admission. Exclusion Criteria: * Any contraindication for nasogastric tube placement including recent injury or pathologic condition of the esophagus. * Major bronchopleural fistula. * Solid organ transplant recipient. * History or current diagnosis of diaphragmatic paralysis. * Non-conventional mechanical ventilation strategy including high frequency oscillation, airway pressure release ventilation, prone ventilation and extra- corporeal membrane oxygenation. * Hemodynamic instability defined as MAP\<65 with multiple vasopressors. * Declining to sign consent form.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility

Timeframe: one year

Trial details

NCT IDNCT02463773

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2022-03-02

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials