Noninvasive estimate of inspiratory effort to monitor pressure support ventilation
Official title: Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation: A Prospective Physiological Study
Run by Capital Medical University · NCT07886892 · Data updated 2026-11-12
This study tests whether a noninvasive computed inspiratory muscle pressure (cPmus) can match the traditional esophageal pressure method for adults on pressure support ventilation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Capital Medical University Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | October 22, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07886892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older on invasive pressure support ventilation who can provide consent or have a legally authorized representative.
✕Probably not a fit
Patients without invasive ventilation or those unable to tolerate esophageal catheter placement may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective validation study compares a noninvasive cPmus estimate from the ventilator with the reference esophageal pressure-derived inspiratory muscle pressure (Pmus) in adults on pressure support ventilation. Participants will have simultaneous recordings at six different pressure support levels, with brief occlusion maneuvers to gather additional respiratory-drive data. Each level lasts 10 minutes, and the esophageal catheter is removed after the final step. Data will include cPmus, Pmus, and derived pressure-time products to assess agreement and accuracy across varying support. The study adheres to standardized measurement procedures and will use electronic database capture for quality checks.
Why it matters
Potential benefit: If successful, clinicians could monitor inspiratory effort noninvasively, reducing the need for esophageal catheters while guiding ventilator settings.
How similar studies have gone: Prior work in ventilatory monitoring has shown promise for noninvasive estimates, though direct validation against esophageal Pmus in this setting is novel/limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older. 2. Receiving pressure support ventilation. 3. Written informed consent provided by the participant or a legally authorized representative. Exclusion Criteria: 1. Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices. 2. Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain. 3. Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery. 4. Impaired central respiratory drive due to intracranial hypertension or brainstem injury. 5. 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. 6. Pregnancy or breastfeeding. 7. A decision to withdraw life-sustaining treatment or provide palliative care.
Where it's running
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Beijing Shijitan Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Jian-Xin Zhou — Capital Medical University
- Study coordinator: Jian-Xin Zhou, MD, PhD
- Email: zhoujx.cn@icloud.com
- Phone: 8610 6392 6666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.