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

Not Applicable

• Conditions: Extubation; Mechanical Ventilation; Weaning
• Interventions: Procedure: High flow oxygen therapy in spontaneous breathing trial

• Registration Number: NCT03929328
• Lead Sponsor: Sang-Min Lee

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 Timeline

• Study First Submitted: 2019-04-20
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Study Start: 2019-06-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spontaneous breathing trial with high flow oxygen therapy	High 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.

Primary Outcome Measures

Name	Time	Method
Rate of weaning failure	Day 2	Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation

Secondary Outcome Measures

Name	Time	Method
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
ICU mortality	From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.	Death in ICU
Rate of reintubation within 48 hr of extubation	Day 2	Reintubation within 48 hr of extubation
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of