Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation: A Prospective Physiological Study
1 other identifier
interventional
30
1 country
1
Brief Summary
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure support ventilation. 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. Researchers will adjust pressure support across six levels, recording measurements from both methods at each level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2026
CompletedFirst Posted
Study publicly available on registry
October 21, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
Study Completion
Last participant's last visit for all outcomes
April 30, 2027
October 21, 2026
October 1, 2026
6 months
October 15, 2026
October 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Computed inspiratory muscle pressure (cPmus)
Computed inspiratory muscle pressure (cPmus) will be measured.
2 hours
Inspiratory muscle pressure (Pmus)
Inspiratory muscle pressure (Pmus) will be measured.
2 hours
Computed inspiratory muscle pressure-time product (cPTPmus)
Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.
2 hours
Inspiratory muscle pressure-time product (PTPmus)
Inspiratory muscle pressure-time product (PTPmus) will be measured.
2 hours
Secondary Outcomes (3)
Occluded airway pressure at 100ms (P0.1)
2 hours
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
2 hours
Pressure muscle index (PMI)
2 hours
Study Arms (6)
Pressure support 15
EXPERIMENTALPressure support of 15 cm H2O will be applied for 10 minutes.
Pressure support 13
EXPERIMENTALPressure support of 13 cm H2O will be applied for 10 minutes.
Pressure support 11
EXPERIMENTALPressure support of 11 cm H2O will be applied for 10 minutes.
Pressure support 9
EXPERIMENTALPressure support of 9 cm H2O will be applied for 10 minutes.
Pressure support 7
EXPERIMENTALPressure support of 7 cm H2O will be applied for 10 minutes.
Pressure support 5
EXPERIMENTALPressure support of 5 cm H2O will be applied for 10 minutes.
Interventions
Pressure support of 15 cm H2O will be applied for 10 minutes.
Pressure support of 13 cm H2O will be applied for 10 minutes.
Pressure support of 11 cm H2O will be applied for 10 minutes.
Pressure support of 9 cm H2O will be applied for 10 minutes.
Pressure support of 7 cm H2O will be applied for 10 minutes.
Pressure support of 5 cm H2O will be applied for 10 minutes.
Eligibility Criteria
You may qualify if:
- Age 18 years or older.
- Receiving pressure support ventilation.
- Written informed consent provided by the participant or a legally authorized representative.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jian-Xin Zhoulead
Study Sites (1)
Beijing Shijitan Hospital
Beijing, China
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Xin Zhou
Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Emergency and Critical Care Center
Study Record Dates
First Submitted
October 15, 2026
First Posted
October 21, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
October 21, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share