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Which breathing aid works best for lung strain? new study aims to find out

NCT ID NCT07247318

Knowledge-focused Sponsor: Southeast University, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will enroll 60 adults with acute hypoxemic respiratory failure (low oxygen levels) to compare three noninvasive breathing supports: CPAP, NIV, and high-flow nasal oxygen. Researchers will use electrical impedance tomography to measure lung strain in real time. The goal is to see which method best reduces uneven air movement in the lungs, which can worsen injury.

What this could mean

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

What this could lead to
If successful, this study could help doctors choose the best breathing support for patients with low oxygen levels, potentially improving recovery.
What could go wrong
This is a small, early-stage study that only measures short-term effects, so results may not apply to all patients or lead to clear treatment changes.

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 60 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

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: * Age ≥ 18 years; * PaO₂/FiO₂ ≤ 300 mmHg or SpO₂/FiO₂ ≤ 315 (with SpO₂ ≤ 97%); * Requiring one of the following respiratory supports: 1. Noninvasive positive pressure ventilation with PEEP ≥ 5 cmH₂O, or 2. High-flow nasal oxygen therapy with a flow rate ≥ 30 L/min, or 3. Conventional oxygen therapy with an oxygen flow ≥ 10 L/min, where FiO₂ is calculated using the formula: FiO₂ = 0.21 + (oxygen flow rate × 0.03). Exclusion Criteria: * Received CPAP or NIV for more than 24 hours prior to screening. * Received invasive mechanical ventilation during the current hospitalization. * Presence of chronic underlying pulmonary disease, or PaCO₂ ≥ 45 mmHg. * Presence of cardiogenic pulmonary edema. * Hemodynamic instability, defined as systolic blood pressure \< 90 mmHg or norepinephrine-equivalent dose \> 0.3 µg/kg/min. * Impaired consciousness (GCS ≤ 12). * Patients requiring urgent intubation, including those with respiratory or cardiac arrest, apnea with loss of consciousness or gasping, or severe hypoxemia (defined as SpO₂ \< 90% despite 100% oxygen). * Contraindications to NIV: cardiac or respiratory arrest, coma, untreated pneumothorax, uncontrollable vomiting, upper airway obstruction, hematemesis or severe facial trauma, or thoracic/abdominal surgery within the past 7 days. * Contraindications to EIT: implanted cardiac pacemaker, unstable spinal injury or fracture, or open chest trauma. * Refusal of endotracheal intubation. * Pregnancy.

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Conditions

The condition(s) this trial relates to.

acute respiratory failure

As listed by the trial registrant

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

Acute respiratory failure (ARF)

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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