Clinical trial NCT03929328: Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients
Official title: A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weaning
Mechanical Ventilation
Extubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of weaning failure
timeFrame: Day 2
Secondary outcomes:
measure: ICU mortality
timeFrame: From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.
measure: In-hospital mortality
timeFrame: From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months.
measure: ICU length of stay
timeFrame: Through the study completion, an average of 1 weeks
measure: Time to reintubation after extubation
timeFrame: From the date of extubation until the date of reintubation, assessed up to 1 weeks.
measure: Rate of reintubation within 48 hr of extubation
timeFrame: Day 2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang-Min Lee, MD
role: STUDY_CHAIR
References:
citation: 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.