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

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

Detailed Description
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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.

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

Conditions
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Ventilator Weaning

Intervention / Treatment
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* Procedure: switching between invasive and noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation. | Procedure: switching between invasive and noninvasive ventilation<br>* As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.<br>|
| No Intervention: Control group<br>Patients in this group are weaned from ventilator as conventional methods. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator weaning days |  | from enrollment to 90 days | 

Secondary Outcome Measures

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