High Flow Nasal CannulaSLOWHNCT03845244
Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy
A study testing Flow reduction first, FiO2 reduction first and Simultaneous (flow and FiO2) reduction in people with High Flow Nasal Cannula and Respiratory Insufficiency, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
High flow nasal cannula oxygen therapy has been widely used in critically ill patients. Despite effectiveness of high flow nasal cannula as a treatment, optimal methods to withdrawal high flow nasal cannula after recovery from preexisting conditions has not been investigated to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Flow Nasal Cannula, Respiratory Insufficiency
- What is being tested?
- Flow reduction first, FiO2 reduction first and Simultaneous (flow and FiO2) reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jan 2019to 31 Mar 2024
- 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
- The patients applying high flow nasal cannula and satisfying the following weaning criteria.
- Patient who has recovered from the underlying condition
- No signs of respiratory distress like agitation, diaphoresis or anxiety
- Arterial pH ≥ 7.35, SpO2 > 90% on FiO2 ≤ 0.5
- Respiratory rate ≤ 25/min, Heart rate ≤120/min, Systolic blood pressure ≥ 90mmHg
Who cannot join
- Severe hypercapnia (pH <7.25)
- Respiratory arrest requiring tracheal intubation
- Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
- Failure of more than two organs
- Recent trauma or burns of the neck and face
- Non- cooperation
- Pregnancy
- Refusal of treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Simultaneous Reduction Versus Flow or Fraction of Inspired Oxygen Reduction First in Patients Ready to Wean From High Flow Nasal Cannula Oxygen Therapy: a Randomized Controlled Trial
High flow nasal cannula oxygen therapy has been widely used in critically ill patients. Despite effectiveness of high flow nasal cannula as a treatment, optimal methods to withdrawal high flow nasal cannula after recovery from preexisting conditions has not been investigated to date. In this study, we will evaluate the efficacy and safety of three different weaning methods in patients with high flow nasal cannula oxygen therapy.
Read the detailed description
Comparison of three weaning strategies: flow reduction first versus fraction of inspired oxygen (FiO2) first versus simultaneous reduction
- Conditions
- High Flow Nasal Cannula, Respiratory Insufficiency
- Being tested
- Flow reduction first, FiO2 reduction first, Simultaneous (flow and FiO2) reduction
- Keywords
- high flow nasal cannula, weaning, adult
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow reduction firstDevice
-10L/min q 1hr
FiO2 reduction firstDevice
- 0.1 q 1hr
Simultaneous (flow and FiO2) reductionDevice
-10L/min and -0.1 q 1hr
| Study group | Role | What they receive |
|---|---|---|
| Flow reduction first group | Active comparator | Flow reduction first -> FiO2 reduction -> conventional oxygen therapy Receives: Device: Flow reduction first |
| FiO2 reduction first group | Active comparator | FiO2 reduction first -> flow reduction -> conventional oxygen therapy Receives: Device: FiO2 reduction first |
| Simultaneous reduction group | Active comparator | Simultaneous (Flow and FiO2) reduction -> conventional oxygen therapy Receives: Device: Simultaneous (flow and FiO2) reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to weaning success
The time to successfully remaining off high flow nasal cannula
Measured: up to 2 weeks
Secondary outcomes (5)
weaning success or failure rate
Success or failure rate to wean off high flow nasal cannula
Measured: up to 2 weeks
change of arterial partial pressure of oxygen, carbon dioxide, and pH
changes of arterial blood gas analyses
Measured: up to 2 weeks
intolerance rate
intolerance to high flow nasal cannula
Measured: up to 2 weeks
hospital length of stay
hospital length of stay
Measured: during hospital admission, up to 12 weeks
In-hospital mortality
all cause mortality
Measured: during hospital admission, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start24 Jan 2019
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
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 High Flow Nasal CannulaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Sun Kim, Seoul National University Bundang Hospital
- Investigators
- Eun Sun Kim, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845244
- Sponsor's protocol ID
- B-1809-492-006
- Acronym
- SLOWH
- Status last verified
- Apr 2024
- First submitted
- 11 Feb 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim T, Kwack WG, Park S, Jung S, Song MJ, Kim ES, Lim SY. Weaning Strategies for High-Flow Nasal Cannula in Critically Ill Adults: A Randomized Clinical Trial. Crit Care Med. 2026 Oct 15. doi: 10.1097/CCM.0000000000007379. Online ahead of print.
PubMed 42878628Kim MC, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee CT, Lee JH, Kim ES. Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). Trials. 2020 Jan 14;21(1):81. doi: 10.1186/s13063-019-4019-7.
PubMed 31937322
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Reduction Versus Flow or Fraction of Inspired Oxygen Reduction First in Patients Ready to Wean From High Flow Nasal Cannula Oxygen Therapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03845244
- Acronym / sponsor ID
- SLOWH / B-1809-492-006
- Conditions
- High Flow Nasal Cannula, Respiratory Insufficiency
- Keywords
- high flow nasal cannula, weaning, adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 19 Feb 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.
High flow nasal cannula oxygen therapy has been widely used in critically ill patients. Despite effectiveness of high flow nasal cannula as a treatment, optimal methods to withdrawal high flow nasal cannula after recovery from preexisting conditions has not been investigated to date. In this study, we will evaluate the efficacy and safety of three different weaning methods in patients with high flow nasal cannula oxygen therapy.
Detailed description
Comparison of three weaning strategies: flow reduction first versus fraction of inspired oxygen (FiO2) first versus simultaneous reduction
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flow reduction first group | Active comparator | Device: Flow reduction firstFlow reduction first -> FiO2 reduction -> conventional oxygen therapy |
| FiO2 reduction first group | Active comparator | Device: FiO2 reduction firstFiO2 reduction first -> flow reduction -> conventional oxygen therapy |
| Simultaneous reduction group | Active comparator | Device: Simultaneous (flow and FiO2) reductionSimultaneous (Flow and FiO2) reduction -> conventional oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients applying high flow nasal cannula and satisfying the following weaning criteria.
Key exclusion criteria (8 listed)
- Severe hypercapnia (pH <7.25)
- Respiratory arrest requiring tracheal intubation
- Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
- Failure of more than two organs
- Recent trauma or burns of the neck and face
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 |
|---|---|---|
| Flow reduction first-10L/min q 1hr | Device | Flow reduction first group |
| FiO2 reduction first- 0.1 q 1hr | Device | FiO2 reduction first group |
| Simultaneous (flow and FiO2) reduction-10L/min and -0.1 q 1hr | Device | Simultaneous reduction group |
Primary outcome
Time to weaning success
Time frame: up to 2 weeks
The time to successfully remaining off high flow nasal cannula
5 secondary outcomes
weaning success or failure rate
Time frame: up to 2 weeks
change of arterial partial pressure of oxygen, carbon dioxide, and pH
Time frame: up to 2 weeks
intolerance rate
Time frame: up to 2 weeks
hospital length of stay
Time frame: during hospital admission, up to 12 weeks
In-hospital mortality
Time frame: during hospital admission, up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 42878628Kim T, Kwack WG, Park S, Jung S, Song MJ, Kim ES, Lim SY. Weaning Strategies for High-Flow Nasal Cannula in Critically Ill Adults: A Randomized Clinical Trial. Crit Care Med. 2026 Oct 15. doi: 10.1097/CCM.0000000000007379. Online ahead of print.
- Derived from this study: PubMed 31937322Kim MC, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee CT, Lee JH, Kim ES. Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). Trials. 2020 Jan 14;21(1):81. doi: 10.1186/s13063-019-4019-7.
- Individual participant dataSharing planned: No
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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.
Eun Sun Kim, MD principal investigator
Seoul National University Bundang 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 Flow reduction first, FiO2 reduction first and Simultaneous (flow and FiO2) reduction in people with High Flow Nasal Cannula and Respiratory Insufficiency, run by Seoul National University Hospital 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 18 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to weaning success (time frame: up to 2 weeks). 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 NCT03845244, 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 18 Apr 2024.