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

Ventilator Weaning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921334
• Other study ID #: cqykdxfsdyyy3
• Status: Recruiting
• Phase: N/A
• First received: September 28, 2016
• Last updated: September 29, 2016
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2016
• Source: Chongqing Medical University
• Contact: Guosheng Ren, MD
• Phone: 02389012680
• Is FDA regulated: No
• Health authority: China: Ethics committee of the first affiliated hospital of chongqing medical university
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ventilator Weaning

Intervention

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

Locations

Country	Name	City	State
China	The first affiated hospital, chongqing medical university	ChongQing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilator weaning days		from enrollment to 90 days	Yes
Secondary	successful weaning rate		from enrollment to 90 days	Yes
Secondary	ICU stay days		from admission to 90 days	Yes
Secondary	hospital stay days		from admission to 90 days	Yes
Secondary	ICU mortality		from admission to 90 days	Yes
Secondary	hospital mortality		from admission to 90 days	Yes