WeaningHOSTNCT03929328
Effect of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients
A study testing High flow oxygen therapy in spontaneous breathing trial in people with Weaning and Mechanical Ventilation, run by Sang-Min Lee at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, Mechanical Ventilation, Extubation
- What is being tested?
- High flow oxygen therapy in spontaneous breathing trial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
- Respiratory criteria :
- PaO2:FIO2 >150 with FIO2 ≤0.4, PEEP <8 cm H2O
Show all 18Show fewer
- Arterial pH >7.35
- Rapid shallow breathing index (RSBI) < 105
- Maximum inspiratory pressure (MIP) < -20 cm H20
- Clinical criteria :
- Absence of electrocardiographic signs of myocardial ischemia
- No vasoactive drugs, or vital signs are stable with using vasoactive drugs
- Heart rate <140/min,
- Hemoglobin >8 g/dL
- Temperature <38°C
- No need for sedatives, or mental status are stable with sedatives
- Presence of respiratory stimulus, and appropriate spontaneous cough
- Absence of excessive tracheobronchial secretions
Who cannot join
- Tracheostomy status
- Decision to stop life-supportive therapies before enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Sang-Min Lee, MD, 82-02-2072-0833, sangmin2@snu.ac.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Weaning, Mechanical Ventilation, Extubation
- Being tested
- High flow oxygen therapy in spontaneous breathing trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow oxygen therapy in spontaneous breathing trialProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Spontaneous breathing trial with T-piece | No intervention | 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. |
| Spontaneous breathing trial with high flow oxygen therapy | Experimental | 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. Receives: Procedure: High flow oxygen therapy in spontaneous breathing trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of weaning failure
Weaning failure is defined as failed to spontaneous breathing trial or reintubation within 48 hr of extubation
Measured: Day 2
Secondary outcomes (5)
ICU mortality
Death in ICU
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start17 Jun 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sang-Min Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sang-Min Lee, Seoul National University Hospital
- Investigators
- Sang-Min Lee, MD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929328
- Sponsor's protocol ID
- HOSTLSM2019
- Acronym
- HOST
- Status last verified
- May 2020
- First submitted
- 20 Apr 2019
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not Provided
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.
PubMed 17470624Lee HY, Lee J, Lee SM. Effect of high-flow oxygen versus T-piece ventilation strategies during spontaneous breathing trials on weaning failure among patients receiving mechanical ventilation: a randomized controlled trial. Crit Care. 2022 Dec 23;26(1):402. doi: 10.1186/s13054-022-04281-w.
PubMed 36564808
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of High Flow Oxygen Therapy in Spontaneous Breathing Trial on Weaning in Mechanical Ventilated Patients.
- ClinicalTrials.gov ID
- NCT03929328
- Acronym / sponsor ID
- HOST / HOSTLSM2019
- Conditions
- Weaning, Mechanical Ventilation, Extubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Sang-Min LeeUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous breathing trial with T-piece | No intervention | –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. |
| Spontaneous breathing trial with high flow oxygen therapy | Experimental | Procedure: High flow oxygen therapy in spontaneous breathing trialPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 :
Key exclusion criteria (2 listed)
- Tracheostomy status
- Decision to stop life-supportive therapies before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow oxygen therapy in spontaneous breathing trialPatients 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 or surgery | Spontaneous breathing trial with high flow oxygen therapy |
Primary outcome
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
5 secondary outcomes
ICU mortality
Time frame: From the date of randomization until the date of ICU death from any cause, assessed up to 1 month.
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.
ICU length of stay
Time frame: Through the study completion, an average of 1 weeks
Time to reintubation after extubation
Time frame: From the date of extubation until the date of reintubation, assessed up to 1 weeks.
Rate of reintubation within 48 hr of extubation
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Background: PubMed 17470624Boles 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.
- Derived from this study: PubMed 36564808Lee HY, Lee J, Lee SM. Effect of high-flow oxygen versus T-piece ventilation strategies during spontaneous breathing trials on weaning failure among patients receiving mechanical ventilation: a randomized controlled trial. Crit Care. 2022 Dec 23;26(1):402. doi: 10.1186/s13054-022-04281-w.
- Individual participant dataSharing planned: No. Not Provided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Min Lee, MD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen therapy in spontaneous breathing trial in people with Weaning and Mechanical Ventilation, run by Sang-Min Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Min Lee, MD (82-02-2072-0833, sangmin2@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of weaning failure (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03929328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.