Skip to main content
Clinical Trials/NCT05026463
NCT05026463
Unknown
Not Applicable

Use of Pressure Muscle Index to Avoid Over-assistance During Pressure Support Ventilation

Capital Medical University2 sites in 1 country20 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mechanical Ventilation
Sponsor
Capital Medical University
Enrollment
20
Locations
2
Primary Endpoint
Inspiratory effort
Last Updated
4 years ago

Overview

Brief Summary

Pressure support ventilation (PSV) is the most commonly used mode in mechanical ventilated patients. Studies have shown that over-assistance was prevalent in patients undergoing PSV. Up to now, no reliable method has been recommended to select an "optimal" inspiratory support level. Pressure muscle index (PMI) was introduced recently to evaluate the degree of spontaneous breathing effort. We hypothesize that PMI might be used as an indicator for over-assistance during PSV. In this randomized crossover study, inspiratory support is set at three levels according to negative, positive and zero PMI. Inspiratory effort, work of breathing, and respiratory mechanics are compared among the three inspiratory pressure support levels.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
February 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Capital Medical University
Responsible Party
Principal Investigator
Principal Investigator

Jian-Xin Zhou

Professor

Capital Medical University

Eligibility Criteria

Inclusion Criteria

  • Mechanical ventilated patients within 48 hours after the transition from a controlled mode to PSV

Exclusion Criteria

  • History of neuromuscular disease
  • History of diaphragm dysfunction and surgery
  • History of esophageal, gastric or lung surgery
  • Decreased level of consciousness
  • Central respiratory drive dysfunction
  • Considered withholding of life support

Outcomes

Primary Outcomes

Inspiratory effort

Time Frame: 30 minutes

Inspiratory effort is measured as pressure generated by inspiratory muscles using esophageal pressure monitoring.

Work of breathing

Time Frame: 30 minutes

Work of breathing is measured by the Campbell diagram and pressure-time-product using esophageal pressure monitoring.

Secondary Outcomes

  • Partial pressure of carbon dioxide in arterial blood (mmHg)(30 minutes)
  • Tidal volume (ml)(30 minutes)
  • Respiratory rate (breaths/min)(30 minutes)
  • Respiratory system compliance (ml/cmH2O)(30 minutes)
  • Rapid shallow breathing index(30 minutes)
  • The use of accessory respiratory muscle(30 minutes)
  • Partial pressure of oxygen in arterial blood (mmHg)(Partial pressure of oxygen in arterial blood)

Study Sites (2)

Loading locations...

Similar Trials