Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05963737

PMI Guide Pressure Support Setting in Ventilated Patients A Prospective Multicenter Randomized Clinical Trial

Led by Capital Medical University · Updated on 2025-01-09

60

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new method to set pressure support ventilation (PSV) using the inspiratory muscle pressure index (PMI) in patients on mechanical ventilation. PSV is commonly used to help patients breathe by providing inspiratory support, but current guidelines for adjusting the pressure support level rely on tidal volume and respiratory rate, which can sometimes lead to too much or too little assistance. This study aims to test whether using PMI to guide pressure support settings can better match patient needs, protect the lungs and diaphragm, and improve ventilation outcomes. The study involves adjusting pressure support settings in patients receiving PSV to keep the PMI within a target range of 0 to 2 cmH2O. PMI is measured noninvasively at the bedside by calculating the difference between plateau pressure and airway peak pressure during a brief airway occlusion. This approach allows dynamic and personalized adjustment of ventilator support. The trial is a prospective multicenter randomized clinical study comparing this PMI-guided strategy against standard care. Participants will be monitored for inspiratory effort over the first 48 hours to assess how often their effort remains within a normal range. Researchers will collect data on lung and diaphragm protection and overall mechanical ventilation outcomes. The study will also evaluate whether using PMI-guided pressure support is practical and feasible in clinical settings. The total participation duration includes at least 48 hours of ventilator support evaluation and monitoring.

CONDITIONS

Official Title

PMI Guide PS Setting in Pressure Support-ventilated Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients under pressure support ventilation (PSV)
  • Predicted ventilated time of more than 48 hours
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Known pregnancy
  • Body mass index (BMI) greater than 35 kg/m2
  • Brain-stem or cervical spinal cord injury
  • Known or suspected elevated intracranial pressure (greater than 18 mmHg)
  • Injury to the phrenic nerve or diaphragm
  • Broncho-pleural fistula
  • Chronic obstructive pulmonary disease (COPD)
  • Pressure support ventilation for more than 48 hours before randomization

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100071

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Use of pressure muscle index to guide pressure support ventilation setting: a study protocol and statistical plan for a prospective randomised controlled proof-of-concept trial.

Ran Gao, Yan-Lin Yang, Linlin Zhang...

https://pubmed.ncbi.nlm.nih.gov/39097307
PMI Guide Pressure Support Setting in Ventilated Patients A Prospective Multicenter Randomized Clinical Trial | DecenTrialz