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Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning

Efficacy and Safety of Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning: a Randomized Control Trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02921334
Enrollment
200
Registered
2016-10-03
Start date
2016-09-01
Completion date
2019-12-30
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Weaning

Brief summary

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

Detailed description

When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient 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.

Interventions

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

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* duration of invasive ventilation 5 to 7 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

Design outcomes

Primary

MeasureTime frame
ventilator weaning daysfrom enrollment to 90 days

Secondary

MeasureTime frame
successful weaning ratefrom enrollment to 90 days
ICU stay daysfrom admission to 90 days
hospital stay daysfrom admission to 90 days
ICU mortalityfrom admission to 90 days
hospital mortalityfrom admission to 90 days

Countries

China

Contacts

PRINCIPAL_INVESTIGATORShuliang Guo, MD

First Affiliated Hospital of Chongqing Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026