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Completed

NCT Number: NCT04140682

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

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.

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Key information

Conditions

Respiratory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAV+ mode

Device

PAV+ mode by using Puritan-Bennett 840 ventilator

PSV mode

Device

PSV mode by using Puritan-Bennett 840 ventilator

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. Hospital length of stay

    Time frame: up to 123 days

    Patients were followed to discharge to calculate the length of hospitalization

  3. 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

  4. Hospital mortality

    Time frame: up to 123 days

    Patients were followed to discharge to calculate the mortality rate during hospitalization.

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2019
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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