Subglottic Stenosis (SGS)THRIVENCT06925282
Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With THRIVE
An observational study of Subglottic Stenosis (SGS), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The anesthesia and surgical procedures from the time the patient enters the operating room to discharge from the recovery room are identical to those used in conventional airway surgeries performed under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subglottic Stenosis (SGS)
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2025to Apr 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled to undergo elective airway surgery under general anesthesia with THRIVE at a single tertiary academic hospital. A total of 80 patients will be prospectively enrolled. All participants will receive standard anesthetic care, and data will be collected during the intraoperative period for analysis of factors associated with the requirement for rescue ventilation.
Who may be able to join
- Adult patients undergoing elective airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE)
- Patients who provide written informed consent
Who cannot join
- Patients who decline to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Kyung Won Shin, 01094810470, skwskw126@gmail.com
About this study
Official title: Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Prospective Observational Study
The anesthesia and surgical procedures from the time the patient enters the operating room to discharge from the recovery room are identical to those used in conventional airway surgeries performed under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). The time point at which rescue ventilation is required due to a drop in oxygen saturation below 92% during anesthesia will be recorded, and the predictive factors for this event will be investigated.
- Conditions
- Subglottic Stenosis (SGS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE | Adult patients undergoing airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Rescue Ventilation Due to Hypoxemia During Airway Surgery With THRIVE Under General Anesthesia
The primary outcome is the time from the start of apnea to the initiation of rescue ventilation, defined as the point when oxygen saturation (SpO₂) falls to 92% or below during airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). This will be measured using continuously recorded intraoperative data. The aim is to identify clinical predictors (e.g., anatomical and physiological variables) associated with the need for rescue ventilation.
Measured: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Secondary outcomes (4)
Lowest Oxygen Saturation After Initiation of Rescue Ventilation
This outcome measures the lowest oxygen saturation (SpO₂) observed after the initiation of rescue ventilation during airway surgery with THRIVE under general anesthesia. Data will be extracted from intraoperative monitoring records.
Measured: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Time to Recovery of SpO₂ to 100% After Rescue Ventilation
This outcome measures the time interval from the start of rescue ventilation to the recovery of oxygen saturation (SpO₂) to 100%. The measurement will help evaluate the efficacy of rescue ventilation in restoring oxygenation.
Measured: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
End-Tidal CO₂ at the Time of Rescue Ventilation
This outcome records the end-tidal carbon dioxide (EtCO₂) level at the moment rescue ventilation is initiated. It aims to assess the extent of CO₂ retention during apnea and its relationship to the timing of rescue ventilation.
Measured: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Predictive Factors for the Requirement of Rescue Ventilation
This outcome involves analysis of patient anatomical and physiological factors (e.g., Mallampati class, thyromental distance, neck circumference, presence of retrognathia) to determine their association with the need for rescue ventilation during THRIVE-supported airway surgery.
Measured: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start25 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subglottic Stenosis (SGS)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin Kyung Won, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925282
- Sponsor's protocol ID
- 2503-107-1622
- Acronym
- THRIVE
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06925282
- Acronym / sponsor ID
- THRIVE / 2503-107-1622
- Conditions
- Subglottic Stenosis (SGS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Apr 2025 (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 anesthesia and surgical procedures from the time the patient enters the operating room to discharge from the recovery room are identical to those used in conventional airway surgeries performed under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). The time point at which rescue ventilation is required due to a drop in oxygen saturation below 92% during anesthesia will be recorded, and the predictive factors for this event will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THRIVE | – | –Adult patients undergoing airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled to undergo elective airway surgery under general anesthesia with THRIVE at a single tertiary academic hospital. A total of 80 patients will be prospectively enrolled. All participants will receive standard anesthetic care, and data will be collected during the intraoperative period for analysis of factors associated with the requirement for rescue ventilation.
Key inclusion criteria (2 listed)
- Adult patients undergoing elective airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE)
- Patients who provide written informed consent
Key exclusion criteria (1 listed)
- Patients who decline to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Rescue Ventilation Due to Hypoxemia During Airway Surgery With THRIVE Under General Anesthesia
Time frame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
The primary outcome is the time from the start of apnea to the initiation of rescue ventilation, defined as the point when oxygen saturation (SpO₂) falls to 92% or below during airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE). This will be measured using continuously recorded intraoperative data. The aim is to identify clinical predictors (e.g., anatomical and physiological variables) associated with the need for rescue ventilation.
4 secondary outcomes
Lowest Oxygen Saturation After Initiation of Rescue Ventilation
Time frame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Time to Recovery of SpO₂ to 100% After Rescue Ventilation
Time frame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
End-Tidal CO₂ at the Time of Rescue Ventilation
Time frame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
Predictive Factors for the Requirement of Rescue Ventilation
Time frame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)
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 24 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subglottic Stenosis (SGS), 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 1 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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?
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 Kyung Won Shin (02-2072-2469, skwskw126@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Rescue Ventilation Due to Hypoxemia During Airway Surgery With THRIVE Under General Anesthesia (time frame: From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)). 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 24 Apr 2026.