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

Mechanical Ventilation Clinical Trial

— HOST  

Official title:

A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929328
• Other study ID #: HOSTLSM2019
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: Seoul National University Hospital
• Contact: Sang-Min Lee, MD
• Phone: 82-02-2072-0833
• Email: sangmin2[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extubation
• Mechanical Ventilation
• Respiratory Aspiration
• Weaning

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sang-Min Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of weaning failure	Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation	Day 2
Secondary	ICU mortality	Death in ICU	From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.
Secondary	In-hospital mortality	Death in hospital	From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months.
Secondary	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
Secondary	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.
Secondary	Rate of reintubation within 48 hr of extubation	Reintubation within 48 hr of extubation	Day 2