HypoxiaHFNOTNCT01650974
High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy
A study testing HFNOT in people with Hypoxia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- HFNOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Nov 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PaO2 < 60 mmHg on ABGA or SpO2 < 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy
- Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.)
Who cannot join
- patients who did not agree to provide information
- patients requiring for emergent intubation
- patients can not wear or be already applied high flow nasal oxygen therapy
- patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.)
- patients with multiple organ failures
- patients with plan to therapeutic bronchoscopic procedure(e.g. intervention)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study
The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.
Read the detailed description
Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.
- Conditions
- Hypoxia
- Being tested
- HFNOT
- Keywords
- high flow nasal oxygen therapy, diagnostic bronchoscopy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNOTDevice
Also called high flow nasal oxygen therapy(OPTIFLOW)
high flow nasal oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| conventional oxygen therapy | No intervention | conventional nasal prong with FiO2 ~0.4 |
| HFNOT | Experimental | high flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min Receives: Device: HFNOT |
| sham-HFNOT | Sham comparator | same device with FiO2 ~0.4, NO high flow Receives: Device: HFNOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of bronchoscopy
Success is defined as completion of planned diagnostic procedure with the oxygen saturation or partial pressure of oxygen in arterial blood was similar to the level of before the procedure.
Failure is defined as incompletion of planned diagnostic procedure due to sustained hypoxemia or else.
Furthermore failure is defined as hypoxemia(SaO2 <88%) was developed more than 2 times even though planned procedure was completed.
Measured: 1 day
Total duration of hypoxia
total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
Measured: 1 day
Secondary outcomes (3)
frequency of hypoxia
frequency of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
Measured: 1 day
switch to oxygen therapy method
Increase oxygen apply or change of oxygen therapy method to high flow system.
Measured: 1 day
change of respiratory symptoms
scoring of dyspnea symptoms, patients comfort.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Jae Cho, Seoul National University Bundang Hospital
- Investigators
- Young-Jae Cho, MD, MPH, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650974
- Sponsor's protocol ID
- E-1205-154-002
- Other IDs
- H-1206-074-414
- Acronym
- HFNOT
- Status last verified
- Apr 2019
- First submitted
- 24 Jul 2012
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal OXygen Therapy in High Risk Patients of Hypoxia Undergoing Diagnostic BRONCHOscopy: A Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01650974
- Acronym / sponsor ID
- HFNOT / E-1205-154-002
- Conditions
- Hypoxia
- Keywords
- high flow nasal oxygen therapy, diagnostic bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 26 Jul 2012 (estimated)
- 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.
The purpose of this study is to determine the efficacy and safety of nasal high flow oxygen therapy during diagnostic bronchoscopy.
Detailed description
Hypoxemia is frequently seen during diagnostic bronchoscopy. Nasal prong or other existing oxygen supply methods are often difficult to maintain adequate oxygenation during bronchoscopy. In particular, bronchoscopy to patients already showing hypoxemia can be dangerous even though applying conventional oxygen therapy. Thus, we want to elucidate the usefulness of nasal high flow oxygen therapy to hypoxemic patients undergoing diagnostic bronchoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional oxygen therapy | No intervention | –conventional nasal prong with FiO2 ~0.4 |
| HFNOT | Experimental | Device: HFNOThigh flow nasal oxygen therapy with starting FiO2 0.4 and Flow 40 L/min |
| sham-HFNOT | Sham comparator | Device: HFNOTsame device with FiO2 ~0.4, NO high flow |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PaO2 < 60 mmHg on ABGA or SpO2 < 90 % in room air AND SpO2 ≥ 95% or PaO2 ≥ 75mmHg in low flow oxygen therapy
- Planning to diagnostic bronchoscopic procedure (e.g. bronchial washing, BAL, bronchoscopic biopsy, EBUS-TBNA etc.)
Key exclusion criteria (6 listed)
- patients who did not agree to provide information
- patients requiring for emergent intubation
- patients can not wear or be already applied high flow nasal oxygen therapy
- patients with unstable vital sign(e.g. severe hypotension, uncontrolled arrhythmia, etc.)
- patients with multiple organ failures
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 |
|---|---|---|
| HFNOTAlso: high flow nasal oxygen therapy(OPTIFLOW)high flow nasal oxygen therapy | Device | HFNOT, sham-HFNOT |
Primary outcome
Success rate of bronchoscopy
Time frame: 1 day
Success is defined as completion of planned diagnostic procedure with the oxygen saturation or partial pressure of oxygen in arterial blood was similar to the level of before the procedure. Failure is defined as incompletion of planned diagnostic procedure due to sustained hypoxemia or else. Furthermore failure is defined as hypoxemia(SaO2 <88%) was developed more than 2 times even though planned procedure was completed.
Total duration of hypoxia
Time frame: 1 day
total duration of hypoxia(oxygen saturation ≤88%) during procedure or after procedure.
3 secondary outcomes
frequency of hypoxia
Time frame: 1 day
switch to oxygen therapy method
Time frame: 1 day
change of respiratory symptoms
Time frame: 1 day
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 19 Apr 2019.
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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.
Young-Jae Cho, MD, MPH 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 HFNOT in people with Hypoxia, 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 2 inclusion and 6 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 19 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
Success rate of bronchoscopy (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2019.