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

Overview

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.

Full Title of Study: “Comparison of Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2011

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.

Interventions

  • Device: PAV+ mode
    • PAV+ mode by using Puritan-Bennett 840 ventilator
  • Device: PSV mode
    • PSV mode by using Puritan-Bennett 840 ventilator

Arms, Groups and Cohorts

  • Experimental: PAV+ mode
    • Weaning with PAV+ mode
  • Active Comparator: PSV mode
    • Weaning with PSV mode

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Weaning duration
    • Time Frame: 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).
  • Hospital length of stay
    • Time Frame: up to 123 days
    • Patients were followed to discharge to calculate the length of hospitalization
  • Weaning success at discharge
    • Time Frame: 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 mortality
    • Time Frame: up to 123 days
    • Patients were followed to discharge to calculate the mortality rate during hospitalization.

Participating in This Clinical Trial

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 < 38ÂșC (within 24 hours).

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaohsiung Veterans General Hospital.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chiu-Fan Chen, Principal Investigator – Kaohsiung Veterans General Hospital.
  • Overall Official(s)
    • Chiu-Fan Chen, MD, Principal Investigator, Kaohsiung Veterans General Hospital.

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