Patients Undergoing Endoscopic Submucosal DissectionNCT06688019
A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection
A study testing conventional oxygenation (nasal cannula) and high-flow humidified oxygen-delivery system (OptiFlow THRIVE) in people with Patients Undergoing Endoscopic Submucosal Dissection, run by Yonsei University.
Trial summary
Sedation for endoscopic submucosal dissection 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 submucosal dissection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients Undergoing Endoscopic Submucosal Dissection
- What is being tested?
- conventional oxygenation (nasal cannula) and high-flow humidified oxygen-delivery system (OptiFlow THRIVE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to 18 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- patients who will undergo endoscopic sumucosal dissection under remimazolam-based sedation
Who cannot join
- dementia or cognitive dysfunction
- altered mental status
- intubated patients or tracheostomy
- pregnancy
- recent history of nasal bleeding
- contraindication for positive pressure ventilation
- patients under oxygen therapy
- illiteracy or foreigner
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Sedation for endoscopic submucosal dissection 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 submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.
- Being tested
- conventional oxygenation (nasal cannula), 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.
conventional oxygenation (nasal cannula)Device
conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.
high-flow humidified oxygen-delivery system (OptiFlow THRIVE)Device
conventional oxygenation arm will receive oxygen at 2 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 |
|---|---|---|
| conventional oxygenation (nasal cannula) arm | Experimental | conventional oxygenation arm will receive oxygen at 2L/min via nasal cannula Receives: Device: conventional oxygenation (nasal cannula) |
| high-flow humidified oxygen-delivery system (OptiFlow THRIVE) arm | Experimental | Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE Receives: Device: 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.
The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure
We will record the incidence of hypoxemia during the procedure.
Measured: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour
Secondary outcomes (4)
the number and duration of hypoxemia
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
Measured: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
the lowest SpO2 during procedure
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
Measured: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
need for airway intervention
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
Measured: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
the end tidal CO2 at the end of the procedure
We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
Measured: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study startNov 2024 (estimated)
- Primary completion18 Oct 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Endoscopic Submucosal DissectionStudies 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: conventional nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688019
- Sponsor's protocol ID
- 4-2024-1108
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT06688019
- Acronym / sponsor ID
- 4-2024-1108
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- 18 Oct 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 14 Nov 2024 (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.
Sedation for endoscopic submucosal dissection 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 submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional 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: conventional nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
| Arm | Type | Receives |
|---|---|---|
| conventional oxygenation (nasal cannula) arm | Experimental | Device: conventional oxygenation (nasal cannula)conventional oxygenation arm will receive oxygen at 2L/min via nasal cannula |
| high-flow humidified oxygen-delivery system (OptiFlow THRIVE) arm | Experimental | Device: 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)
- patients who will undergo endoscopic sumucosal dissection under remimazolam-based sedation
Key exclusion criteria (8 listed)
- dementia or cognitive dysfunction
- altered mental status
- intubated patients or tracheostomy
- pregnancy
- 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 |
|---|---|---|
| conventional oxygenation (nasal cannula)conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure. | Device | conventional oxygenation (nasal cannula) arm |
| high-flow humidified oxygen-delivery system (OptiFlow THRIVE)conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure. | Device | high-flow humidified oxygen-delivery system (OptiFlow THRIVE) arm |
Primary outcome
The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure
Time frame: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour
We will record the incidence of hypoxemia during the procedure.
4 secondary outcomes
the number and duration of hypoxemia
Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
the lowest SpO2 during procedure
Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
need for airway intervention
Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
the end tidal CO2 at the end of the procedure
Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing conventional oxygenation (nasal cannula) and high-flow humidified oxygen-delivery system (OptiFlow THRIVE) in people with Patients Undergoing Endoscopic Submucosal Dissection, run by Yonsei University.
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 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: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Namo Kim (82-2-2224-3200, namo@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure (time frame: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour). 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 14 Nov 2024.