Tiny study on lung support in ARDS halted early

NCT ID NCT03202641

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to compare two ways of setting breathing machine pressure (PEEP) in patients with severe lung injury (ARDS). The goal was to see which method better protects the lungs and heart. Only 2 patients were enrolled before the study was stopped, so no meaningful results were obtained.

What this could mean

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

What could go wrong: The study was terminated early with only 2 participants, so no reliable conclusions can be drawn. Results may not apply to other ARDS patients.

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

2 people

The number who actually took part.

Started

Jun 2019

Finished

May 2020

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 to 85 years

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: * ARDS diagnosis within 72h after intubation * Severe to moderate ARDS (PaO2 / FiO2 \< 200 mmHg) with PEEP\>5 cmH2O * Presence of an arterial line * Between 18 and 85 years old Exclusion Criteria: * Persistent systolic blood pressure \< 90 mmHg and/or \>180 mmHg despite the use of vasopressor or vasodilators * Increment in vasopressors over the past two hour just before enrollment of: more than 15 mcg/min for norepinephrine and dopamine, more than 10 mcg/min in epinephrine; and more than 50 mcg/ min for phenylephrine. * Advanced lung disease confirmed by computed tomography findings * Presence or history of pneumothorax * Severe coagulopathy (INR ≥ 4) * Severe thrombocytopenia (Platelets count ≤ 5,000/mm3) * Usage of any devices with electric current generation such as pacemaker or internal cardiac defibrillator * Recent esophageal trauma or surgery * Known presence of esophageal varices * Pregnancy

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome adult acute respiratory distress syndrome heart failure pulmonary edema respiratory distress syndrome in premature infants Ventricular Dysfunction, Right

As listed by the trial registrant

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

Alveolar edema ARDS, human Lung injury, acute Mechanical ventilation complication Respiratory distress syndrome Right heart failure Right ventricular dysfunction

Tiny study on lung support in ARDS halted early

What the study statuses mean