Computed inspiratory muscle pressure to monitor inspiratory effort during pressure-targeted assist/control ventilation

Is this trial a fit for you?

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 receiving pressure-targeted assist/control ventilation with spontaneous breathing. Participants will undergo simultaneous monitoring at four PEEP levels, each maintained for 10 minutes, with additional occlusion maneuvers to gather driving and effort indices. Paired cPmus and Pmus values will be analyzed, along with computed pressure-time products (cPTPmus and PTPmus). Data will be collected in case report forms and an electronic database following standardized procedures. The goal is to determine how closely the noninvasive cPmus tracks the invasive reference across varying PEEP while maintaining a constant inspiratory pressure setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Noninvasive estimate of inspiratory effort to monitor pressure support ventilation

  This study tests whether a noninvasive computed inspiratory muscle pressure (cPmus) can match the traditional esophageal pressure method for adults on pressure support ventilation.

  Recruiting Capital Medical University · Beijing · NCT07886892

• ICU rehabilitation for adults on invasive mechanical ventilation

  This project will look at rehabilitation approaches used in ICUs worldwide to see if they relate to outcomes for adults who have been on invasive mechanical ventilation for at least 48 hours.

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• Comparing high-flow tracheal oxygen and T-piece for breathing trials

  This study is testing whether a new type of high-flow oxygen or a standard T-piece helps patients who are coming off mechanical ventilation breathe better during trials.

  Recruiting Capital Medical University · Beijing, Beijing Municipality · NCT06816706

• Pulse Wave vs Saline Bolus EIT to measure lung perfusion in ARDS

  This study tests whether pulse wave EIT or saline bolus EIT can best show lung blood flow in ARDS patients on mechanical ventilation.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07908368

• Driving pressure-guided individualized PEEP vs standard PEEP during upper abdominal surgery

  In this randomized trial, adults at higher risk of breathing problems after upper abdominal surgery will try a personalized PEEP level based on the lowest driving pressure and compare it to a fixed PEEP of 5 cmH2O to see if it lowers postoperative lung complications.

  Recruiting Hopital Charles Nicolle · Tunis · NCT07885124

• Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults

  This study tests how different patient breathing efforts relate to breathlessness in adults on assisted mechanical ventilation.

  Recruiting University of Crete · Heraklion · NCT07877350

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.