Switching Between Invasive and Noninvasive Ventilation to... | NCT02921347

Studies
Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning in Difficult-weaning Patients

NCT02921347

Sponsor

Chongqing Medical University

Status

Terminated

Last Update Posted

Mar 24, 2026Actual

Enrollment

83Actual

Phase

Not Applicable

Conditions

Ventilator Weaning

Interventions

switching between invasive and noninvasive ventilation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficult patient enrollment.

Expanded Access Info

Start Date

Sep 30, 2016Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Sep 28, 2016

First Submission Date that Met QC Criteria

Sep 29, 2016

First Posted Date

Oct 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to facilitate weaning by switching between invasive and noninvasive ventilation in difficult-weaning patients.

Detailed Description

This study only enrolled patients with tracheotomy. When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.A patient in intervention group is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
switching between invasive and noninvasive ventilation	Procedure	As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ventilator weaning days		from enrollment to 90 days

Secondary Outcomes

Measure	Description	Time Frame
successful weaning rate		from enrollment to 90 days
ICU stay days		from admission to 90 days
hospital stay days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

duration of invasive ventilation ≥14 days
anticipation of difficult weaning
Glasgow Coma Scale ≥13
no upper airway obstruction
presence of spontaneous breath

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shuliang Guo, MD	First Affiliated Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiated hospital, chongqing medical university		Chongqing	Chongqing Municipality	400016	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D063087	Noninvasive Ventilation

Ancestor Terms

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy

Browse Leaves

Not provided

Browse Branches

Not provided