ClinicalTrials.Veeva

Menu

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

C

Capital Medical University

Status

Unknown

Conditions

Mechanical Ventilation

Treatments

Procedure: Inspiratory support level

Study type

Interventional

Funder types

Other

Identifiers

NCT05026463
KY2021-012-01

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 3 patient groups

Inspiratory support level with PMI equal to -2
Experimental group
Description:
PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.
Treatment:
Procedure: Inspiratory support level
Inspiratory support level with PMI equal to 0
Experimental group
Description:
PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.
Treatment:
Procedure: Inspiratory support level
Inspiratory support level with PMI equal to +2
Experimental group
Description:
PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.
Treatment:
Procedure: Inspiratory support level

Trial contacts and locations

2

Loading...

Central trial contact

Jian-Xin Zhou, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems