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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140682
• Other study ID #: VGHKS99-CT14-15
• Status: Completed
• Phase: N/A
• Start date: May 1, 2010
• Est. completion date: April 30, 2011

Study information

• Verified date: October 2019
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 30, 2011
• Est. primary completion date: April 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiration, Artificial
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day weaning success rate	Weaning success was defined as being alive and liberation from MV for more than 48 hours.	28 days
Secondary	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
Secondary	Hospital length of stay	Patients were followed to discharge to calculate the length of hospitalization	up to 123 days
Secondary	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
Secondary	Hospital mortality	Patients were followed to discharge to calculate the mortality rate during hospitalization.	up to 123 days