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

Study Overview
=================
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.

Official Title
-----------------
Comparison of Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial

Conditions
-----------------
Respiratory Failure, Respiration, Artificial

Intervention / Treatment
-----------------
* Device: PAV+ mode
* Device: PSV mode


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAV+ mode<br>Weaning with PAV+ mode | Device: PAV+ mode<br>* PAV+ mode by using Puritan-Bennett 840 ventilator<br>|
| Active Comparator: PSV mode<br>Weaning with PSV mode | Device: PSV mode<br>* PSV mode by using Puritan-Bennett 840 ventilator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning duration | 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). | up to 28 days | 
| Hospital length of stay | Patients were followed to discharge to calculate the length of hospitalization | up to 123 days | 
| Weaning success at discharge | 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 | up to 123 days | 
| Hospital mortality | Patients were followed to discharge to calculate the mortality rate during hospitalization. | up to 123 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proportional assist ventilation, Pressure support ventilation, Weaning, Prolonged mechanical ventilation