An interventional study of Positive end-expiratory pressure 11 and Positive end-expiratory pressure 9 in Mechanical Ventilation and Critical Care, sponsored by Jian-Xin Zhou. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Jian-Xin Zhou · Not applicable, Interventional, and Diagnostic
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure-targeted assist/control ventilation (P-A/C) who retain spontaneous breathing. Participants initiate their own breaths, with assistance from the ventilator. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results.
Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter during assisted P-A/C ventilation. Researchers will adjust positive end-expiratory pressure (PEEP) across four levels. The inspiratory pressure setting will remain unchanged. Researchers will record measurements from both methods at each PEEP level.
This is a prospective validation study with repeated measurements. It aims to validate computed inspiratory muscle pressure (cPmus), a noninvasive estimate of inspiratory muscle pressure provided by the study ventilator (Prunus Padus 9, Shenzhen, China). The reference method is esophageal pressure-derived inspiratory muscle pressure (Pmus). The study will enroll adults receiving invasive pressure-targeted assist/control ventilation (P-A/C) who retain spontaneous breathing and receive ventilator assistance for patient-triggered breaths.
After obtaining informed consent, participants will undergo simultaneous monitoring with the cPmus algorithm and an esophageal balloon catheter. Positive end-expiratory pressure (PEEP) will be adjusted in four levels while the inspiratory pressure setting remains unchanged. Each level will be maintained for 10 minutes. Brief end-expiratory and end-inspiratory occlusion maneuvers will also be performed at each level to obtain additional indices of respiratory drive and inspiratory effort. Esophageal balloon will be removed after completing the last pressure support step.
At each PEEP level, paired values of cPmus and reference Pmus were measured. The corresponding inspiratory pressure-time products, cPTPmus and PTPmus, will also be calculated.
All procedures will follow the study protocol and standardized measurement procedures. Study data will be recorded in case report forms and an electronic database, with checks for completeness, accuracy, and waveform quality.
Jian-Xin Zhou is the lead sponsor of 11 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes.
Procedure: Positive end-expiratory pressure 11
Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes.
Procedure: Positive end-expiratory pressure 9
Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes.
Procedure: Positive end-expiratory pressure 7
Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes.
Procedure: Positive end-expiratory pressure 5
Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes.
Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes.
Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes.
Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes.
Computed inspiratory muscle pressure (cPmus)
Computed inspiratory muscle pressure (cPmus) will be measured.
Time frame: 2 hours
Inspiratory muscle pressure (Pmus)
Inspiratory muscle pressure (Pmus) will be measured.
Time frame: 2 hours
Computed inspiratory muscle pressure-time product (cPTPmus)
Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.
Time frame: 2 hours
Inspiratory muscle pressure-time product (PTPmus)
Inspiratory muscle pressure-time product (PTPmus) will be measured.
Time frame: 2 hours
Occluded airway pressure at 100ms (P0.1)
Occluded airway pressure at 100ms (P0.1) will be measured.
Time frame: 2 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured.
Time frame: 2 hours
Pressure muscle index (PMI)
Pressure muscle index (PMI) will be measured.
Time frame: 2 hours
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Jian-Xin Zhou