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

• ClinicalTrials.gov Identifier: NCT03929328
• Recruitment Status: Recruiting
• First Posted: April 26, 2019
• Last Update Posted: May 28, 2020
• Sponsor: Sang-Min Lee
• Information provided by (Responsible Party): Sang-Min Lee, Seoul National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Weaning; Mechanical Ventilation; Extubation	Procedure: High flow oxygen therapy in spontaneous breathing trial	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.
• Actual Study Start Date: June 17, 2019
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. ICU mortality [ Time Frame: From the date of randomization until the date of ICU death from any cause, assessed up to 1 month. ]
   Death in ICU
2. In-hospital mortality [ Time Frame: From the date of randomization until the date of in-hospital death from any cause, assessed up to 3 months. ]
   Death in hospital
3. ICU length of stay [ Time Frame: 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
4. Time to reintubation after extubation [ Time Frame: 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
5. Rate of reintubation within 48 hr of extubation [ Time Frame: Day 2 ]
   Reintubation within 48 hr of extubation

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Sang-Min Lee, MD; 82-02-2072-0833; sangmin2@snu.ac.kr

Contact: Hong Yeul Lee, MD; 82-02-2072-1094; takumama@naver.com

Locations

Korea, Republic of

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Contact: Sang-Min Lee, MD 82-02-2072-0833 sangmin2@snu.ac.kr

Sponsors and Collaborators

Sang-Min Lee

Investigators

• Study Chair: Sang-Min Lee, MD; Seoul National University Hospital

More Information

Publications:

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.

• Responsible Party: Sang-Min Lee, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03929328
• Other Study ID Numbers: HOSTLSM2019
• First Posted: April 26, 2019
• Last Update Posted: May 28, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Not Provided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes