CompletedNot Applicable

Use of Endotracheal Tube Cuff Pressure to Assess Inspiratory Effort During Pressure Support Ventilation

China30 participantsStarted 2025-05-20

Plain-language summary

During pressure support ventilation (PSV), monitoring of Esophageal Pressure (Pes) has long been considered the gold standard for assessing intrathoracic pressure and the state of respiratory mechanics.The aim of this study was to investigate the correlation between Cuff Pressure (Pcuff) and Esophageal Pressure in patients undergoing tracheal intubation or tracheotomy, and to assess whether Pcuff can be used as a surrogate for Pes for reflecting changes in intrathoracic pressure.The correlation and its consistency between the two under different ventilation conditions were analysed by synchronously monitoring the ΔPcuff and ΔPes to further validate the potential application value of cuff pressure in clinical practice.The results of the study will provide a more convenient and non-invasive method of monitoring intrathoracic pressure in mechanically ventilated patients, thus optimising ventilation strategies, reducing complications, and promoting the innovation and development of monitoring technology in the field of critical care medicine.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Mechanically ventilated patients who can tolerate pressure support ventilation (PSV) mode;
. 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%;
. 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);
. Metabolic stability, with an esophageal pressure monitoring catheter already placed prior to the trial;
. Written informed consent obtained from the patient or their legal guardian.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tidal swing of endotracheal tube cuff pressure (ΔPcuff)

Timeframe: From enrollment to the end of treatment at 4 hours

Tidal swing of esophageal pressure (∆Pes)

Timeframe: From enrollment to the end of treatment at 4 hours

Esophageal pressure-time product (PTP)

Timeframe: From enrollment to the end of treatment at 4 hours

Inspiratory muscle pressure (Pmus)

Timeframe: From enrollment to the end of treatment at 4 hours

Trial details

NCT IDNCT06968793

SponsorJian-Xin Zhou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Mechanical Ventilation trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Mechanically ventilated patients who can tolerate pressure support ventilation (PSV) mode;
. 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%;
. 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);
. Metabolic stability, with an esophageal pressure monitoring catheter already placed prior to the trial;
. Written informed consent obtained from the patient or their legal guardian.

Exclusion criteria

What they're measuring

Tidal swing of endotracheal tube cuff pressure (ΔPcuff)

Timeframe: From enrollment to the end of treatment at 4 hours

Tidal swing of esophageal pressure (∆Pes)

Timeframe: From enrollment to the end of treatment at 4 hours

Esophageal pressure-time product (PTP)

Timeframe: From enrollment to the end of treatment at 4 hours

Inspiratory muscle pressure (Pmus)

Timeframe: From enrollment to the end of treatment at 4 hours