NCT02921334

Brief Summary

The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

September 28, 2016

Last Update Submit

March 20, 2026

Conditions

Ventilator Weaning

Outcome Measures

Primary Outcomes (1)

  • ventilator weaning days

    from enrollment to 90 days

Secondary Outcomes (5)

  • successful weaning rate

    from enrollment to 90 days

  • ICU stay days

    from admission to 90 days

  • hospital stay days

    from admission to 90 days

  • ICU mortality

    from admission to 90 days

  • hospital mortality

    from admission to 90 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation.

Procedure: switching between invasive and noninvasive ventilation

Control group

NO INTERVENTION

Patients in this group are weaned from ventilator as conventional methods.

Interventions

switching between invasive and noninvasive ventilationPROCEDURE

As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.

Intervention group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • duration of invasive ventilation 5 to 7 days
  • anticipation of difficult weaning
  • Glasgow Coma Scale ≥13
  • no upper airway obstruction
  • presence of spontaneous breath

You may not qualify if:

  • age less than 18 or more than 85 years;
  • contraindications for noninvasive ventilation;
  • anticipation of survival less than 6 months;
  • refusal of tracheotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiated hospital, chongqing medical university

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Shuliang Guo, MD

    First Affiliated Hospital of Chongqing Medical University

    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
MD

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 3, 2016

Study Start

September 1, 2016

Primary Completion

September 30, 2019

Study Completion

December 30, 2019

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

CN(1)