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Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With THRIVE

Determinants of Rescue Ventilation Requirement in Airway Surgery Under General Anesthesia With Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06925282
Acronym
THRIVE
Enrollment
80
Registered
2025-04-13
Start date
2025-04-25
Completion date
2028-04-01
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subglottic Stenosis (SGS)

Brief 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). 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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients undergoing elective airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) * Patients who provide written informed consent

Exclusion criteria

* Patients who decline to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Time to Rescue Ventilation Due to Hypoxemia During Airway Surgery With THRIVE Under General AnesthesiaFrom 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.

Secondary

MeasureTime frameDescription
Lowest Oxygen Saturation After Initiation of Rescue VentilationFrom the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)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.
Time to Recovery of SpO₂ to 100% After Rescue VentilationFrom the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)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.
End-Tidal CO₂ at the Time of Rescue VentilationFrom the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)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.
Predictive Factors for the Requirement of Rescue VentilationFrom the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)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.

Countries

South Korea

Contacts

CONTACTKyung Won Shin
skwskw126@gmail.com02-2072-2469

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026