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

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.

Study Overview

• Status: Recruiting
• Conditions: Subglottic Stenosis (SGS)

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Kyung Won Shin; Phone Number: 02-2072-2469; Email: skwskw126@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Contact: Kyung Won Shin; Phone Number: 01094810470; Email: skwskw126@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
THRIVE; Adult patients undergoing airway surgery under general anesthesia with Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2503-107-1622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No