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出境医 / 临床实验 / Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients (HOST)

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

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
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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
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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
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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
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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
Layout table for investigator information
Study Chair: Sang-Min Lee, MD Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE April 20, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
  • Rate of reintubation within 48 hr of extubation [ Time Frame: Day 2 ]
    Reintubation within 48 hr of extubation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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
  • 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
  • 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
  • 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
  • Rate of reintubation within 48 hr of extubation [ Time Frame: Day 2 ]
    Reintubation within 48 hr of extubation
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients
Official Title  ICMJE A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Weaning
  • Mechanical Ventilation
  • Extubation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: High flow oxygen therapy in spontaneous breathing trial
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929328
Other Study ID Numbers  ICMJE HOSTLSM2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not Provided
Responsible Party Sang-Min Lee, Seoul National University Hospital
Study Sponsor  ICMJE Sang-Min Lee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sang-Min Lee, MD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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