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NCT Number: NCT06925282

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Kyung Won Shin

CONTACT

[email protected]

01094810470

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kyung Won Shin

CONTACT

[email protected]

02-2072-2469

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: THRIVE

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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