Ventilator showdown: which pressure setting saves lungs best?

NCT ID NCT06697717

Knowledge-focused Sponsor: XiaoJing Zou,MD Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This study looks at 20 patients who have both high pressure in their belly (intra-abdominal hypertension) and severe lung injury (ARDS). Researchers will compare two methods for setting the ventilator's positive end-expiratory pressure (PEEP): one based on lung pressure measurements and another using electrical impedance tomography (EIT) imaging. The goal is to see which method better improves lung function and avoids harming other organs. This is a small, early study to gather knowledge, not to test a new treatment.

What this could mean

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

Active substance: ventilator pressure setting methods
What this could lead to: If successful, this could identify a better way to set ventilator pressures for patients with both high abdominal pressure and lung injury, potentially reducing lung damage and improving outcomes.
What could go wrong: This is a very small, early-stage study with only 20 participants, so results may not apply to all patients. It compares two methods but does not test a new drug or device, so direct patient benefits are uncertain.

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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

15 people

The number who actually took part.

Started

Dec 2024

Finished

Feb 2026

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 80 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: 1. age: 18-80 years; 2. meets IAH ≥12 mmHg; 3. meets the diagnostic criteria of the Berlin definition of ARDS; 4. PaO2/FiO2 ≤ 200; 5. within 36 hours of invasive mechanical ventilation; 6. patients or their family members were consulted, agreed to participate in the trial, and signed an informed consent form. Exclusion Criteria: 1. Age \<18 years or age \>80 years; 2. uncorrected shock of any type; 3. chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia; 4. pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery; 5. non-invasive ventilation or transnasal high-flow oxygen; 6. with relevant contraindications to the application of EIT (large chest skin injuries, infections, pacemaker implanters, in vivo automatic defibrillator implantation, etc.) pneumothorax, mediastinal emphysema, massive pleural effusion; 7. oesophageal obstruction, oesophageal perforation, severe oesophageal variceal bleeding, upper gastrointestinal surgery, and other factors that make it impossible to place an oesophageal pressure catheter; 8. diaphragmatic hernia, thoracic deformity; patients with obvious pulmonary hernias; 9. prolongation of prothrombin time (PT), activated partial thromboplastin time (APTT) to two times the high limit of normal values or with active bleeding in the nasopharynx; 10. severe neurological disease: intracranial hypertension or neuromuscular disease, etc; 11. pregnant and lactating women; 12. patients to be treated with ECMO; 13. re-admission to the ICU of patients who have already been included in this study, or who are participating in other clinical studies;

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome Intra-Abdominal Hypertension

As listed by the trial registrant

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

Acute respiratory distress syndrome (ARDS) Intra-abdominal hypertension

Contacts and locations

Locations

Wuhan Union Hospital

Wuhan, Hubei, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.