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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02921347
Other study ID # cqykdxfsdyyy4
Secondary ID
Status Recruiting
Phase N/A
First received September 28, 2016
Last updated September 29, 2016
Start date September 2016
Est. completion date September 2019

Study information

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

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date September 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 =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

Study Design

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


Related Conditions & MeSH terms


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
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