New study tests better breathing support for critically ill patients

NCT ID NCT07231107

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Recruiting now
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Not yet recruiting
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 This study
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 Results may not be published yet.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)

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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 90 adults with severe ARDS (a serious lung condition) who were on breathing machines. It compared two ways of using the machine to open up the lungs and improve oxygen levels. The goal was to see which method works better using ultrasound and blood oxygen measurements.

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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

90 people

The number who actually took part.

Started

Aug 2022

Finished

Jul 2024

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 60 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: * Age between 18-60 years old. * Sex: both males and females * Accepts health volunteers: No * all Patients who were mechanically ventilated and diagnosed to have ARDS due to sepsis according to Berlin definition. During the course of the study, a new global definition for ARDS was introduced. To ensure our findings align with the most updated classification, we modified our inclusion criteria to incorporate the new global definition. Patients meeting the Berlin Definition or the new definition were included. Berlin Definition of the acute respiratory distress syndrome (ARDS) Acute Respiratory Distress Syndrome Timing Within 1 week of a known clinical insult or new or worsening respiratory Symptoms Chest imaging Bilateral opacities - not fully explained by effusion, lobar/lung collapse, or nodules. Origin of edema Respiratory failure not fully explained by cardiac failure or fluid overload need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present. Oxygenation Mild 200 mmHg \<Pao2/Fio2 \< 300 mmHg with PEEP or CPAP \> 5 cmH2O. Moderate 100 mmHg \<Pao2/Fio2 \< 200 mmHg with PEEP \> 5 cmH2O. Severe Pao2/Fio2 \< 100 mmHg with PEEP \> 5 cmH2O. (Gordon D, et al; 2012). Diagnostic Criteria for the New Global Definition of ARDS Acute Respiratory Distress Syndrome Risk factors and origin of edema Precipitated by an acute predisposing risk factor, such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock. Pulmonary edema is not exclusively or primarily attributable to cardiogenic pulmonary edema/fluid overload, and hypoxemia/gas exchange abnormalities are not primarily attributable to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if a predisposing risk factor for ARDS is also present. Timing Acute onset or worsening of hypoxemic respiratory failure within 1 week of the estimated onset of the predisposing risk factor or new or worsening respiratory symptoms. Chest imaging Bilateral opacities on chest radiography and computed tomography or bilateral B lines and/or consolidations on ultrasound\* not fully explained by effusions, atelectasis, or nodules / masses. Oxygenation Non-intubated ARDS Intubated ARDS Modified Definition for Resource-Limited Settings * PaO2:FIO2\<300mmHg or * SpO2:FIO2\<315 (if SpO2\<97%) on HFNO with flow of \>30 L/min or NIV/CPAP with at least 5 cm H2O end-expiratory pressure Mild: * 200\<PaO2:FIO2\<300 mm Hg Or * 235\<SpO2:FIO2\<315 (if SpO2\<97%) Moderate: * 100, PaO2:FIO2\<200 mm Hg or * 148\<SpO2:FIO2\<235 (if SpO2\<97%) Severe: * PaO2:FIO2\<100 mm Hg or * SpO2:FIO2\<148 (if SpO2\<97%) • SpO2:FIO2\<315 (if SpO2\<97%). * Neither positive end-expiratory pressure nor a minimum flow rate of oxygen is required for diagnosis in resource-limited settings. (Matthay MA, et al; 2024). Exclusion Criteria: * Patient refusal * Patient with advanced cardiac disorders (rheumatic or ischemic). * Patients with COPD, pneumothorax, surgical emphysema. * Patients with advanced liver or renal disorders * Patients with advanced malignancy. * Female patients during pregnancy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Ainshams University

    Cairo, Abbasia, 00202, Egypt

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