Extubation, Mechanical Ventilation, Weaning
Conditions
Brief summary
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
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.
Interventions
PROCEDUREHigh flow oxygen therapy in spontaneous breathing trial
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.
Sponsors
Sang-Min Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 : 1. Respiratory criteria : 1. PaO2:FIO2 \>150 with FIO2 ≤0.4, PEEP \<8 cm H2O 2. Arterial pH \>7.35 3. Rapid shallow breathing index (RSBI) \< 105 4. Maximum inspiratory pressure (MIP) \< -20 cm H20 2. Clinical criteria : 1. Absence of electrocardiographic signs of myocardial ischemia 2. No vasoactive drugs, or vital signs are stable with using vasoactive drugs 3. Heart rate \<140/min, 4. Hemoglobin \>8 g/dL 5. Temperature \<38°C 6. No need for sedatives, or mental status are stable with sedatives 7. Presence of respiratory stimulus, and appropriate spontaneous cough 8. Absence of excessive tracheobronchial secretions
Exclusion criteria
* Tracheostomy status * Decision to stop life-supportive therapies before enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of weaning failure | Day 2 | Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality | From the date of randomization until the date of ICU death from any cause, assessed up to 1 month. | Death in ICU |
| In-hospital mortality | From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months. | Death in hospital |
| ICU length of stay | Through the study completion, an average of 1 weeks | Duration in days from day of first spontaneous breathing trial to day of discharge from the ICU |
| Time to reintubation after extubation | From the date of extubation until the date of reintubation, assessed up to 1 weeks. | Duration in times from time of extubation to time of reintubation |
| Rate of reintubation within 48 hr of extubation | Day 2 | Reintubation within 48 hr of extubation |
Countries
South Korea
Contacts
Primary ContactSang-Min Lee, MD
Backup ContactHong Yeul Lee, MD
Outcome results
None listed