A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Rate of weaning failure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 :
- •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
Arms & Interventions
Spontaneous breathing trial with T-piece
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
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.
Intervention: High flow oxygen therapy in spontaneous breathing trial (Procedure)
Outcomes
Primary Outcomes
Rate of weaning failure
Time Frame: Day 2
Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation
Secondary Outcomes
- In-hospital mortality(From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months.)
- ICU length of stay(Through the study completion, an average of 1 weeks)
- ICU mortality(From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.)
- Rate of reintubation within 48 hr of extubation(Day 2)
- Time to reintubation after extubation(From the date of extubation until the date of reintubation, assessed up to 1 weeks.)
Investigators
Sang-Min Lee
Associate Professor
Seoul National University Hospital