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New breathing tech aims to free ICU patients from ventilators faster

NCT ID NCT05219643

Disease control 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
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 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 Results may not be published yet.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)

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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a newer breathing support method called NAVA helps patients with ARDS come off mechanical ventilation faster than standard PSV. 130 tracheotomy patients were randomly assigned to one of the two methods. The main goal was to see how many days patients were alive and free from the ventilator within 28 days.

What this could mean

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

Active substance
NAVA (neurally-adjusted ventilatory assist) device
What this could lead to
If successful, NAVA could become a standard method to help patients with ARDS breathe on their own faster, reducing time on a ventilator.
What could go wrong
This is a completed trial with 130 participants, so results are limited. NAVA may not improve weaning success or ICU outcomes compared to standard care.

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

130 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2025

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: 1. Tracheotomy and invasive mechanical ventilation is expected to be required for \> 48h; 2. When support pressure ≤ 15 cmH2O, it can withstand pressure support ventilation (PSV) time \> 1h; Exclusion Criteria: 1. Age \< 18 years or \> 85 years; 2. Deep sedation. 3. Severe hemodynamic instability (norepinephrine or equivalent converted dose of other vasoactive drugs \> 1ug / kg.min or map ≤ 65mmhg) 4. Severe respiratory center depression, high paraplegia, neuromuscular disease; 5. Esophageal obstruction, esophageal perforation, severe esophageal variceal bleeding, upper gastrointestinal surgery, diaphragmatic hernia and thoracic deformity; 6. Patients with chronic respiratory diseases requiring long-term home oxygen therapy; 7. Patients with severe coagulation dysfunction (INR \> 1.5, APTT \> 44s, history of leukemia); 8. Severe other organ dysfunction is expected to die in a short time (7 days) or palliative treatment. 9. The estimated survival time of advanced solid organ or hematological system tumors is \< 30 days 10. Participate in other clinical studies within 30 days; 11. Failing to sign the informed consent form;

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome

As listed by the trial registrant

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

ARDS

Contacts and locations

Locations

  • Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001, China

  • Zhongda Hospital

    Nanjing, Jiangsu, 210009, China

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