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Could a simple cuff pressure replace invasive breathing monitors?

NCT ID NCT06968793

Knowledge-focused Sponsor: Jian-Xin Zhou Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether measuring the pressure in the cuff of a breathing tube can accurately assess how hard a patient is working to breathe while on a ventilator. Researchers compared this new method to the standard, more invasive technique that uses a sensor in the esophagus. Thirty stable patients on ventilators were tested at different breathing support levels. The goal is to find a simpler way to monitor breathing effort and improve ventilator care.

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 could lead to a simpler, less invasive way to monitor breathing effort in patients on ventilators, potentially improving care.
What could go wrong
This is a small, early physiological study with only 30 participants. The method may not be accurate enough for all patients or situations.

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

30 people

The number who actually took part.

Started

May 2025

Finished

Dec 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 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: 1. Mechanically ventilated patients who can tolerate pressure support ventilation (PSV) mode; 2. Respiratory stability: Ability to breathe spontaneously and effectively clear secretions via coughing; oxygen saturation (SpO₂) \>90% or a partial pressure of oxygen (PaO₂)/FiO₂ ratio ≥150 mmHg when the ventilator's oxygen concentration is set to 40%; 3. Hemodynamic stability: Heart rate (HR) ≤120 bpm, systolic blood pressure (SBP) 90-150 mmHg, with no vasoactive agents or norepinephrine dosage ≤0.1-0.2 μg/kg·min (or equivalent doses of other vasoactive agents); 4. Metabolic stability, with an esophageal pressure monitoring catheter already placed prior to the trial; 5. Written informed consent obtained from the patient or their legal guardian. Exclusion Criteria: 1. Age \<18 years; 2. Pregnancy; 3. Hemodynamic instability: Mean arterial pressure (MAP) \<60 mmHg, heart rate (HR) \>120 bpm or \<60 bpm; 4. Respiratory instability: Respiratory rate (RR) \>35 bpm or oxygen saturation (SpO₂) \<90%; 5. Neuromuscular disorders or phrenic nerve injury; 6. Recent trauma or surgery involving the trachea, esophagus, neck, or thorax, contraindications to esophageal catheter insertion, or inability to monitor esophageal pressure; 7. High bleeding risk: Severe coagulopathy/bleeding disorders, esophageal/gastric varices, etc.

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As listed by the trial registrant

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

Critical care Inspiratory effort Mechanical ventilation

Contacts and locations

Locations

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100038, China

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