Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone PositionNCT03872674
A Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
A study testing high-flow humidified oxygen-delivery system (OptiFlow THRIVE) in people with Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position, run by Yonsei University at 1 site in South Korea.
Trial summary
Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position
- What is being tested?
- high-flow humidified oxygen-delivery system (OptiFlow THRIVE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 18 Apr 2019
- 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
- 1. patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation
Who cannot join
- 1. dementia or cognitive dysfunction
- 2. altered mental status
- 3. intubated patients or tracheostomy
- 4. pregnancy
- 5. recent history of nasal bleeding
- 6. illiteracy or foreigner
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.
- Being tested
- high-flow humidified oxygen-delivery system (OptiFlow THRIVE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-flow humidified oxygen-delivery system (OptiFlow THRIVE)Biological
stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| standard oxygenation(nasal cannula) | No intervention | stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula |
| high-flow humidified oxygen-delivery system(OptiFlow THRIVE) | Experimental | Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE Receives: Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowest SpO2 measured with pulse oximetry during the procedure
The investigators will record the lowest SpO2 during the procedure.
Measured: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
Secondary outcomes (1)
incidence of desaturation below 90% during the procedure
The investigators will compare the incidence of desaturation during the procedure between the two groups.
Measured: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Apr 2019
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone PositionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: standard nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872674
- Sponsor's protocol ID
- 1-2018-0082
- Status last verified
- May 2019
- First submitted
- 11 Mar 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim SH, Bang S, Lee KY, Park SW, Park JY, Lee HS, Oh H, Oh YJ. Comparison of high flow nasal oxygen and conventional nasal cannula during gastrointestinal endoscopic sedation in the prone position: a randomized trial. Can J Anaesth. 2021 Apr;68(4):460-466. doi: 10.1007/s12630-020-01883-2. Epub 2021 Jan 6.
PubMed 33403549
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
- ClinicalTrials.gov ID
- NCT03872674
- Acronym / sponsor ID
- 1-2018-0082
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 13 Mar 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.
Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: standard nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
| Arm | Type | Receives |
|---|---|---|
| standard oxygenation(nasal cannula) | No intervention | –stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula |
| high-flow humidified oxygen-delivery system(OptiFlow THRIVE) | Experimental | Biological: high-flow humidified oxygen-delivery system (OptiFlow THRIVE)Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation
Key exclusion criteria (6 listed)
- 1. dementia or cognitive dysfunction
- 2. altered mental status
- 3. intubated patients or tracheostomy
- 4. pregnancy
- 5. recent history of nasal bleeding
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 humidified oxygen-delivery system (OptiFlow THRIVE)stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure. | Biological | high-flow humidified oxygen-delivery system(OptiFlow THRIVE) |
Primary outcome
lowest SpO2 measured with pulse oximetry during the procedure
Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
The investigators will record the lowest SpO2 during the procedure.
1 secondary outcome
incidence of desaturation below 90% during the procedure
Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
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 9 May 2019.
- Derived from this study: PubMed 33403549Kim SH, Bang S, Lee KY, Park SW, Park JY, Lee HS, Oh H, Oh YJ. Comparison of high flow nasal oxygen and conventional nasal cannula during gastrointestinal endoscopic sedation in the prone position: a randomized trial. Can J Anaesth. 2021 Apr;68(4):460-466. doi: 10.1007/s12630-020-01883-2. Epub 2021 Jan 6.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 humidified oxygen-delivery system (OptiFlow THRIVE) in people with Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position, run by Yonsei University 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 1 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 9 May 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. 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?
lowest SpO2 measured with pulse oximetry during the procedure (time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)). 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 NCT03872674, which also lists 1 linked publication.
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 9 May 2019.