Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General AnesthesiaNCT04291339
Comparison of the Efficacy of High-flow Nasal Oxygen Therapy and Facial Mask Ventilation on the Increase of the Oxygen Reserve Index During Anesthetic Induction
A study testing High-flow nasal oxygen technique and Mask ventilation technique in people with Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the ability of oxygenation with high-flow nasal oxygen therapy and mask ventilation technique for induction of anesthesia in adult patients who are planning to undergo surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
- What is being tested?
- High-flow nasal oxygen technique and Mask ventilation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2020to 12 Jan 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged over 19 years who are scheduled for sleep endoscopy
Who cannot join
- basal skull fracture
- facial anomaly
- consciousness disorder
- Risk of aspiration
- necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
About this study
The purpose of this study is to compare the ability of oxygenation with high-flow nasal oxygen therapy and mask ventilation technique for induction of anesthesia in adult patients who are planning to undergo surgery under general anesthesia.
- Conditions
- Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
- Being tested
- High-flow nasal oxygen technique, Mask ventilation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal oxygen techniqueProcedure or surgery
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
Mask ventilation techniqueProcedure or surgery
Oxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal oxygen technique | Experimental | High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously. Receives: Procedure: High-flow nasal oxygen technique |
| Mask ventilation technique | Active comparator | Oxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously. Receives: Procedure: Mask ventilation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen reserve index value
Oxygen reserve index will be monitored continuously during anesthetic induction.
Measured: for 10 minutes during anesthetic induction. At Day 0.
Secondary outcomes (1)
The time to achieve the peak oxygen reserve index value
Oxygen reserve index will be monitored continuously during anesthetic induction.
Measured: for 10 minutes during anesthetic induction. At Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start11 Nov 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
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 Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General AnesthesiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 198 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
- NCT04291339
- Sponsor's protocol ID
- 4-2019-1336
- Status last verified
- May 2021
- First submitted
- 28 Feb 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park S, Kim SY, Kim MS, Park WK, Byon HJ, Kim HJ. Comparison of preoxygenation efficiency measured by the oxygen reserve index between high-flow nasal oxygenation and facemask ventilation: a randomised controlled trial. BMC Anesthesiol. 2023 May 9;23(1):159. doi: 10.1186/s12871-023-02126-9.
PubMed 37161369
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of High-flow Nasal Oxygen Therapy and Facial Mask Ventilation on the Increase of the Oxygen Reserve Index During Anesthetic Induction
- ClinicalTrials.gov ID
- NCT04291339
- Acronym / sponsor ID
- 4-2019-1336
- Conditions
- Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 2 Mar 2020 (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.
The purpose of this study is to compare the ability of oxygenation with high-flow nasal oxygen therapy and mask ventilation technique for induction of anesthesia in adult patients who are planning to undergo surgery under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal oxygen technique | Experimental | Procedure: High-flow nasal oxygen techniqueHigh-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously. |
| Mask ventilation technique | Active comparator | Procedure: Mask ventilation techniqueOxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients aged over 19 years who are scheduled for sleep endoscopy
Key exclusion criteria (5 listed)
- basal skull fracture
- facial anomaly
- consciousness disorder
- Risk of aspiration
- necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or 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 nasal oxygen techniqueHigh-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously. | Procedure or surgery | High-flow nasal oxygen technique |
| Mask ventilation techniqueOxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously. | Procedure or surgery | Mask ventilation technique |
Primary outcome
Peak oxygen reserve index value
Time frame: for 10 minutes during anesthetic induction. At Day 0.
Oxygen reserve index will be monitored continuously during anesthetic induction.
1 secondary outcome
The time to achieve the peak oxygen reserve index value
Time frame: for 10 minutes during anesthetic induction. At Day 0.
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 1 Jun 2021.
- Derived from this study: PubMed 37161369Park S, Kim SY, Kim MS, Park WK, Byon HJ, Kim HJ. Comparison of preoxygenation efficiency measured by the oxygen reserve index between high-flow nasal oxygenation and facemask ventilation: a randomised controlled trial. BMC Anesthesiol. 2023 May 9;23(1):159. doi: 10.1186/s12871-023-02126-9.
- Individual participant dataSharing planned: No
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 nasal oxygen technique and Mask ventilation technique in people with Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia, 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 5 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 1 Jun 2021. 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?
Peak oxygen reserve index value (time frame: for 10 minutes during anesthetic induction. At Day 0.). 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 NCT04291339, 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 1 Jun 2021.