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Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure-Targeted Assist/Control Ventilation

NCT07886918 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-21

Condition(s) studied

Mechanical VentilationCritical Care

Investigational drug(s) / intervention(s)

Positive end-expiratory pressure 11Positive end-expiratory pressure 9Positive end-expiratory pressure 7Positive end-expiratory pressure 5

Positive end-expiratory pressure 11: Positive end-expiratory pressure of 11 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 9: Positive end-expiratory pressure of 9 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 7: Positive end-expiratory pressure of 7 cm H2O will be applied for 10 minutes.

Positive end-expiratory pressure 5: Positive end-expiratory pressure of 5 cm H2O will be applied for 10 minutes.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 years or older. 2. Receiving pressure-targeted assist/control ventilation. 3. Retaining spontaneous breathing. 4. 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.

Primary outcome measure(s)

  • Computed inspiratory muscle pressure (cPmus) — 2 hours
    Computed inspiratory muscle pressure (cPmus) will be measured.
  • Inspiratory muscle pressure (Pmus) — 2 hours
    Inspiratory muscle pressure (Pmus) will be measured.
  • Computed inspiratory muscle pressure-time product (cPTPmus) — 2 hours
    Computed inspiratory muscle pressure-time product (cPTPmus) will be measured.
  • Inspiratory muscle pressure-time product (PTPmus) — 2 hours
    Inspiratory muscle pressure-time product (PTPmus) will be measured.

Trial sites (1)

FacilityCityRegionStatus
Beijing Shijitan Hospital Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07886918 on ClinicalTrials.gov ↗ ← All trials in China