Mechanical VentilationNCT07886918
Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation
A study testing Positive end-expiratory pressure 11, Positive end-expiratory pressure 9 and Positive end-expiratory pressure 7 in people with Mechanical Ventilation and Critical Care, run by Jian-Xin Zhou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Critical Care
- What is being tested?
- Positive end-expiratory pressure 11, Positive end-expiratory pressure 9 and Positive end-expiratory pressure 7
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Receiving pressure-targeted assist/control ventilation.
- Retaining spontaneous breathing.
- Written informed consent provided by the participant or a legally authorized representative.
Who cannot join
- Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
- Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
- Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
- Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
- Hemodynamic instability, defined as mean arterial pressure <60 mmHg, systolic blood pressure >180 mmHg, heart rate <40 or >150 beats/min, or norepinephrine dose >1 mcg/kg/min.
- Pregnancy or breastfeeding.
- A decision to withdraw life-sustaining treatment or provide palliative care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meng-Xue Hou, MD contact
China1 site
Beijing Shijitan Hospital
Beijing
Jian-Xin Zhou, MD, PhD, 8610 6392 6666, zhoujx.cn@icloud.com
Meng-Xue Hou, MD, himengxue@163.com
About this study
Official title: Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation: A Prospective Physiological Study
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.
Read the detailed description
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.
- Conditions
- Mechanical Ventilation, Critical Care
- Being tested
- Positive end-expiratory pressure 11, Positive end-expiratory pressure 9, Positive end-expiratory pressure 7, Positive end-expiratory pressure 5
- Keywords
- Esophageal pressure, Mechanical ventilation, Inspiratory effort, Inspiratory muscle pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory pressure 11Procedure or surgery
Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes.
Positive end-expiratory pressure 9Procedure or surgery
Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes.
Positive end-expiratory pressure 7Procedure or surgery
Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes.
Positive end-expiratory pressure 5Procedure or surgery
Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Positive end-expiratory pressure 11 | Experimental | Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes. Receives: Procedure: Positive end-expiratory pressure 11 |
| Positive end-expiratory pressure 9 | Experimental | Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes. Receives: Procedure: Positive end-expiratory pressure 9 |
| Positive end-expiratory pressure 7 | Experimental | Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes. Receives: Procedure: Positive end-expiratory pressure 7 |
| Positive end-expiratory pressure 5 | Experimental | Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes. Receives: Procedure: Positive end-expiratory pressure 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computed inspiratory muscle pressure (cPmus)
Computed inspiratory muscle pressure (cPmus) will be measured.
Measured: 2 hours
Inspiratory muscle pressure (Pmus)
Inspiratory muscle pressure (Pmus) will be measured.
Measured: 2 hours
Computed inspiratory muscle pressure-time product (cPTPmus)
Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.
Measured: 2 hours
Inspiratory muscle pressure-time product (PTPmus)
Inspiratory muscle pressure-time product (PTPmus) will be measured.
Measured: 2 hours
Secondary outcomes (3)
Occluded airway pressure at 100ms (P0.1)
Occluded airway pressure at 100ms (P0.1) will be measured.
Measured: 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.
Measured: 2 hours
Pressure muscle index (PMI)
Pressure muscle index (PMI) will be measured.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-Xin Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886918
- Sponsor's protocol ID
- IIT2026-033-002
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation: A Prospective Physiological Study
- ClinicalTrials.gov ID
- NCT07886918
- Acronym / sponsor ID
- IIT2026-033-002
- Conditions
- Mechanical Ventilation, Critical Care
- Keywords
- Esophageal pressure, Mechanical ventilation, Inspiratory effort, Inspiratory muscle pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jian-Xin ZhouUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Positive end-expiratory pressure 11 | Experimental | Procedure: Positive end-expiratory pressure 11Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes. |
| Positive end-expiratory pressure 9 | Experimental | Procedure: Positive end-expiratory pressure 9Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes. |
| Positive end-expiratory pressure 7 | Experimental | Procedure: Positive end-expiratory pressure 7Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes. |
| Positive end-expiratory pressure 5 | Experimental | Procedure: Positive end-expiratory pressure 5Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Receiving pressure-targeted assist/control ventilation.
- Retaining spontaneous breathing.
- Written informed consent provided by the participant or a legally authorized representative.
Key exclusion criteria (7 listed)
- Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
- Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
- Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
- Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
- Hemodynamic instability, defined as mean arterial pressure <60 mmHg, systolic blood pressure >180 mmHg, heart rate <40 or >150 beats/min, or norepinephrine dose >1 mcg/kg/min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive end-expiratory pressure 11Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes. | Procedure or surgery | Positive end-expiratory pressure 11 |
| Positive end-expiratory pressure 9Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes. | Procedure or surgery | Positive end-expiratory pressure 9 |
| Positive end-expiratory pressure 7Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes. | Procedure or surgery | Positive end-expiratory pressure 7 |
| Positive end-expiratory pressure 5Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes. | Procedure or surgery | Positive end-expiratory pressure 5 |
Primary outcome
Computed inspiratory muscle pressure (cPmus)
Time frame: 2 hours
Computed inspiratory muscle pressure (cPmus) will be measured.
Inspiratory muscle pressure (Pmus)
Time frame: 2 hours
Inspiratory muscle pressure (Pmus) will be measured.
Computed inspiratory muscle pressure-time product (cPTPmus)
Time frame: 2 hours
Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.
Inspiratory muscle pressure-time product (PTPmus)
Time frame: 2 hours
Inspiratory muscle pressure-time product (PTPmus) will be measured.
3 secondary outcomes
Occluded airway pressure at 100ms (P0.1)
Time frame: 2 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Time frame: 2 hours
Pressure muscle index (PMI)
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meng-Xue Hou, MD contact
Jian-Xin Zhou principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive end-expiratory pressure 11, Positive end-expiratory pressure 9 and Positive end-expiratory pressure 7 in people with Mechanical Ventilation and Critical Care, run by Jian-Xin Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD, PhD (8610 6392 6666, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed inspiratory muscle pressure (cPmus) (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.