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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous breathing trial with T-piece | No Intervention | 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. | |
| Spontaneous breathing trial with high flow oxygen therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow oxygen therapy in spontaneous breathing trial | Procedure | 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. |
| 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 |
| 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 |
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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 :
Clinical criteria :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Min Lee, MD | Contact | 82-02-2072-0833 | sangmin2@snu.ac.kr | |
| Hong Yeul Lee, MD | Contact | 82-02-2072-1094 | takumama@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang-Min Lee, MD | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17470624 | Background | Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206. | |
| 36564808 | Derived | Lee HY, Lee J, Lee SM. Effect of high-flow oxygen versus T-piece ventilation strategies during spontaneous breathing trials on weaning failure among patients receiving mechanical ventilation: a randomized controlled trial. Crit Care. 2022 Dec 23;26(1):402. doi: 10.1186/s13054-022-04281-w. |
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| 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 |