Using PMI to guide pressure support settings in ventilated patients

PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Multicenter Clinical RCT

This study tests if using a new method to set breathing support on ventilators can help patients who need mechanical ventilation breathe better and recover more effectively.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05963737 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical validity of a pressure support ventilation (PSV) setting strategy guided by the inspiratory muscle pressure index (PMI) in patients requiring mechanical ventilation. The traditional PSV settings often lead to excessive or insufficient assistance, and this study aims to evaluate whether a PMI-guided approach can optimize inspiratory effort and improve outcomes. By measuring PMI, which correlates with inspiratory effort, the study seeks to enhance lung and diaphragm protection while assessing the feasibility of this new ventilation strategy. The primary focus is on patients under PSV for more than 48 hours.

Who should consider this trial

Good fit: Ideal candidates are patients under pressure support ventilation with a predicted ventilated time of more than 48 hours.

Not a fit: Patients under 18 years old, those with certain respiratory conditions, or those who have been on pressure support ventilation for more than 48 hours prior to randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved mechanical ventilation outcomes and better respiratory muscle protection for patients.

How similar studies have performed: While the concept of using PMI in ventilation settings is promising, it is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Patients under PSV
* Predicted ventilated time of more than 48 hours.

Exclusion Criteria:

* Age less than 18 years old;
* Known pregnancy;
* BMI\>35kg/m2;
* Brain-stem or cervical cord injury;
* Known or clinically suspected elevated intracranial pressure (ICP\>18 mmHg);
* Nervus phrenicus or diaphragm injury;
* Broncho-pleural fistula;
* Chronic obstructive pulmonary disease (COPD);
* Pressure support ventilated time more than 48 hours before randomization.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Conditions Mechanical Ventilation; pressure support ventilation; inspiratory effort; inspiratory muscle pressure index