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

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ClinicalTrials.gov Identifier: NCT03929328
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sang-Min Lee, Seoul National University Hospital

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.

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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 : June 16, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929328


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

Publications:
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Responsible Party: Sang-Min Lee, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03929328     History of Changes
Other Study ID Numbers: HOSTLSM2019
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not Provided

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