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

NCT06925282 | Recruiting DMC

• 1 other identifier: 2503-107-1622
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Subglottic Stenosis (SGS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lowest Oxygen Saturation After Initiation of Rescue Ventilation

  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

  From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)

• End-Tidal CO₂ at the Time 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

  From the start of apnea to the initiation of rescue ventilation during surgery (intraoperative period)

Study Arms (1)

THRIVE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who decline to participate in the study

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

Kyung Won Shin

CONTACT

02-2072-2469; skwskw126@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical instructor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 13, 2025
• Study Start: April 25, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2025-04

Locations

KR (1)