Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients

Study Overview
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Brief Summary
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This clinical trial is aimed to show a spontaneous breathing trial using high flow oxygen therapy may lower weaning failure rate and reintubation rate than using T-piece.

Detailed Description
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We project to test the effect of high flow oxygen therapy in spontaneous breathing trial on weaning in mechanical ventilated patients. Patients will be randomly assigned to undergo a spontaneous breathing trial in one of two ways: with a T-piece therapy or with high flow oxygen therapy. Primary end-points are rate of weaning failure and rate of reintubation within 48 hr of extubation. Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation. Secondary end-points are ICU mortality, in-hospital mortality, ICU length of stay, time to reintubation after extubation. Study sample was calculated to detect ability of high flow oxygen therapy to reduce weaning failure from 42 to 15 percent, at two-tailed alpha error of 5% and power of 85% and 98 patients are needed in each arm.

Official Title
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A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.

Conditions
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Weaning, Mechanical Ventilation, Extubation

Intervention / Treatment
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* Procedure: High flow oxygen therapy in spontaneous breathing trial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged 18 years or more, both gender Receiving endotracheal intubation and mechanical ventilation for more than 12 hours Recovery from the precipitating illness Weaning readiness according to the following criteria : Respiratory criteria : PaO2:FIO2 >150 with FIO2 ≤0.4, PEEP <8 cm H2O Arterial pH >7.35 Rapid shallow breathing index (RSBI) < 105 Maximum inspiratory pressure (MIP) < -20 cm H20 Clinical criteria : Absence of electrocardiographic signs of myocardial ischemia No vasoactive drugs, or vital signs are stable with using vasoactive drugs Heart rate <140/min, Hemoglobin >8 g/dL Temperature <38°C No need for sedatives, or mental status are stable with sedatives Presence of respiratory stimulus, and appropriate spontaneous cough Absence of excessive tracheobronchial secretions Exclusion Criteria: Tracheostomy status Decision to stop life-supportive therapies before enrollment

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| No Intervention: Spontaneous breathing trial with T-piece<br>Patients were randomized to undergo a spontaneous breathing trial with T-piece that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation. | |
| Experimental: Spontaneous breathing trial with high flow oxygen therapy<br>Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation. | Procedure: High flow oxygen therapy in spontaneous breathing trial<br>* Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of weaning failure | Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Death in ICU | From the date of randomization until the date of ICU death from any cause, assessed up to 1 month. | 
| In-hospital mortality | Death in hospital | From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months. | 
| ICU length of stay | Duration in days from day of first spontaneous breathing trial to day of discharge from the ICU | Through the study completion, an average of 1 weeks | 
| Time to reintubation after extubation | Duration in times from time of extubation to time of reintubation | From the date of extubation until the date of reintubation, assessed up to 1 weeks. | 
| Rate of reintubation within 48 hr of extubation | Reintubation within 48 hr of extubation | Day 2 |