Back to resultsProportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Ventilation
Primary Purpose
Respiratory Failure, Respiration, Artificial
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PAV+ mode
PSV mode
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring Proportional assist ventilation, Pressure support ventilation, Weaning, Prolonged mechanical ventilation
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.
Sites / Locations
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PAV+ mode
PSV mode
Arm Description
Weaning with PAV+ mode
Weaning with PSV mode
Outcomes
Primary Outcome Measures
28-day weaning success rate
Weaning success was defined as being alive and liberation from MV for more than 48 hours.
Secondary Outcome Measures
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).
Hospital length of stay
Patients were followed to discharge to calculate the length of hospitalization
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
Hospital mortality
Patients were followed to discharge to calculate the mortality rate during hospitalization.
Full Information
NCT ID
NCT04140682
First Posted
October 24, 2019
Last Updated
October 28, 2019
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT04140682
Brief Title
Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Ventilation
Official Title
Comparison of Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
April 30, 2011 (Actual)
Study Completion Date
April 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Respiration, Artificial
Keywords
Proportional assist ventilation, Pressure support ventilation, Weaning, Prolonged mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAV+ mode
Arm Type
Experimental
Arm Description
Weaning with PAV+ mode
Arm Title
PSV mode
Arm Type
Active Comparator
Arm Description
Weaning with PSV mode
Intervention Type
Device
Intervention Name(s)
PAV+ mode
Intervention Description
PAV+ mode by using Puritan-Bennett 840 ventilator
Intervention Type
Device
Intervention Name(s)
PSV mode
Intervention Description
PSV mode by using Puritan-Bennett 840 ventilator
Primary Outcome Measure Information:
Title
28-day weaning success rate
Description
Weaning success was defined as being alive and liberation from MV for more than 48 hours.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Weaning duration
Description
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).
Time Frame
up to 28 days
Title
Hospital length of stay
Description
Patients were followed to discharge to calculate the length of hospitalization
Time Frame
up to 123 days
Title
Weaning success at discharge
Description
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
Time Frame
up to 123 days
Title
Hospital mortality
Description
Patients were followed to discharge to calculate the mortality rate during hospitalization.
Time Frame
up to 123 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Fan Chen, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
ZIP/Postal Code
81362
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Ventilation
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