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

Not yet recruiting

• Conditions: Subglottic Stenosis (SGS)

• Registration Number: NCT06925282
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-31
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Rescue Ventilation Due to Hypoxemia During Airway Surgery With THRIVE Under General Anesthesia	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.

Secondary Outcome Measures

Name	Time	Method
Lowest Oxygen Saturation After Initiation of Rescue Ventilation	From 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 Ventilation	From 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 Ventilation	From 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 Ventilation	From 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.