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

Not Applicable

• Conditions: Ventilator Weaning

• Registration Number: NCT02921334
• Lead Sponsor: Chongqing Medical University

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.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-29
• Last Update Submitted: 2016-09-29
• Study First Posted: 2016-10-03
• Last Update Posted: 2016-10-03
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ventilator weaning days	from enrollment to 90 days

Secondary Outcome Measures

Name	Time	Method
hospital stay days	from admission to 90 days
successful weaning rate	from enrollment to 90 days
ICU stay days	from admission to 90 days
ICU mortality	from admission to 90 days
hospital mortality	from admission to 90 days

Trial Locations

Locations (1)

The first affiated hospital, chongqing medical university; 🇨🇳 ChongQing, Chongqing, China