Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05881863

Conditions

Central Airway Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

Brief summary:

Thermal ablation (use of treatment modalities that generate heat) has become a widely used tool for treatment of central airway obstruction (e.g. laser, electrocautery, radiofrequency, and argon plasma coagulation). However, this method carries with it an increased risk for airway fire - a surgical fire that occurs in a patient's airway and could also include a fire in the attached breathing circuit. To decrease the risk of airway fire during mechanical ventilation with an endotracheal tube, the concentration of inspired oxygen (FiO2) is set below 40% while waiting for end tidal oxygen concentration (EtO2) to fall below 40% prior to starting thermal ablation. There is no published literature describing O2 concentration within the airways (AiO2) during jet ventilation with rigid bronchoscopy. The co-investigators of this study have recently collected data on AiO2 during rigid bronchoscopy using manual low frequency jet ventilation/high frequency jet ventilation with a period of apnea. The intent of this study is to measure the time taken for the central airway oxygen concentration to drop from 90 to 40% when the "laser mode" is activated on the Monsoon jet ventilator. Ventilation is continued during "laser mode."

Conditions

Central Airway Obstruction

Study ID

NCT05881863

Start date

Jan 12, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.
  • 18 years or older
  • Need rigid bronchoscopy as pre-determined by the interventional pulmonologist

Exclusion Criteria:

  • Refusal to sign consent
  • Pregnant patients
  • Hemodynamic instability defined as continuous infusion of medication in order to support blood pressure and/or heart rate/rhythm
  • Respiratory instability defined as SpO2\<90% with \>90% supplemental oxygen.
  • Ineligible for rigid bronchoscopic intubation
  • Latex allergy
  • Evidence of fistulous airway
  • Active Bronchopleural fistula

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

No intervention

This is an observational study

Primary outcome measure

  • Time in seconds to AiO2 from 90 to 40% [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Candace Nelson

nelso377@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-07.