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
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AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
How is the study designed?
Frequently Asked Questions
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
You may qualify if you...
Patients under pressure support ventilation (PSV)
Predicted ventilated time of more than 48 hours
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Frequently Asked Questions
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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.