NCT04140682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2011

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

October 24, 2019

Last Update Submit

October 28, 2019

Conditions

Respiratory FailureRespiration, Artificial

Keywords

Proportional assist ventilationPressure support ventilationWeaningProlonged mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 28-day weaning success rate

    Weaning success was defined as being alive and liberation from MV for more than 48 hours.

    28 days

Secondary Outcomes (4)

  • Weaning duration

    up to 28 days

  • Hospital length of stay

    up to 123 days

  • Weaning success at discharge

    up to 123 days

  • Hospital mortality

    up to 123 days

Study Arms (2)

PAV+ mode

EXPERIMENTAL

Weaning with PAV+ mode

Device: PAV+ mode

PSV mode

ACTIVE COMPARATOR

Weaning with PSV mode

Device: PSV mode

Interventions

PAV+ modeDEVICE

PAV+ mode by using Puritan-Bennett 840 ventilator

PAV+ mode
PSV modeDEVICE

PSV mode by using Puritan-Bennett 840 ventilator

PSV mode

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chiu-Fan Chen, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 28, 2019

Study Start

May 1, 2010

Primary Completion

April 30, 2011

Study Completion

April 30, 2011

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)