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

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

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.

Study Overview

• Status: Unknown
• Conditions: Extubation; Mechanical Ventilation; Weaning
• Intervention / Treatment: Procedure: High flow oxygen therapy in spontaneous breathing trial

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 Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang-Min Lee, MD; Phone Number: 82-02-2072-0833; Email: sangmin2@snu.ac.kr
• Study Contact Backup: Name: Hong Yeul Lee, MD; Phone Number: 82-02-2072-1094; Email: takumama@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sang-Min Lee, MD; Phone Number: 82-02-2072-0833; Email: sangmin2@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of weaning failure	Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation	Day 2

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General 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. doi: 10.1183/09031936.00010206.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2019
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: April 20, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (ACTUAL): April 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HOSTLSM2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not Provided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No