Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Ventilation

Not Applicable

Completed

• Conditions: Respiration, Artificial; Respiratory Failure
• Interventions: Device: PAV+ mode; Device: PSV mode

• Registration Number: NCT04140682
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

A prospective randomized controlled trial was conducted to collect patients with prolonged mechanical ventilation. Patients were randomly assigned to receive PAV+ or PSV as weaning mode. Weaning outcomes were compared between 2 groups.

Detailed Description

Pressure support ventilation (PSV) the most frequently used mode of ventilator support in intensive care units, but has several demerits. Proportional assist ventilation with load-adjustable gain factors (PAV+) is a promising mode with better patient synchrony and weaning advantages. However, weaning outcome of PAV+ in patients with prolonged mechanical ventilation has not been evaluated before. We conducted a prospective randomized controlled trial in a tertiary medical center. This study aimed to compare the effectiveness between PAV+ and PSV for weaning adult patients with prolonged mechanical ventilation.

Study Timeline

• Study Start: 2010-05-01
• Primary Completion: 2011-04-30
• Study Completion: 2011-04-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients with prolonged mechanical ventilation and transfer to respiratory care center, age of 20 years or older, at least 1 time of extubation failure or spontaneous breathing trial failure in ICU, stable hemodynamics, no vasopressor use, FiO2 = 0.40 or less, external positive end-expiratory pressure = 5 cmH2O or less, PaO2 > 60 mmHg, and body temperature < 38ºC (within 24 hours).

Exclusion Criteria

• Patients with bronchopleural fistulas, central neurological disorders, hemodialysis, and those with pressure support level already < 15 cmH2O.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAV+ mode	PAV+ mode	Weaning with PAV+ mode
PSV mode	PSV mode	Weaning with PSV mode

Primary Outcome Measures

Name	Time	Method
28-day weaning success rate	28 days	Weaning success was defined as being alive and liberation from MV for more than 48 hours.

Secondary Outcome Measures

Name	Time	Method
Weaning duration	up to 28 days	Weaning duration was defined as the time from randomization to successful liberation from MV. For those who failed to liberate from MV throughout the course of weaning trial, the weaning duration was defined from randomization to the end of study (up to 28 days).
Weaning success at discharge	up to 123 days	Patients were followed to discharge to calculate weaning success rate at discharge, which is defined as status of being alive and successful weaned at patient discharge
Hospital length of stay	up to 123 days	Patients were followed to discharge to calculate the length of hospitalization
Hospital mortality	up to 123 days	Patients were followed to discharge to calculate the mortality rate during hospitalization.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Taiwan