To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation

Recruiting

• Conditions: Central Airway Obstruction

• Registration Number: NCT05881863
• Lead Sponsor: University of Minnesota

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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-31
• Study Start: 2023-08-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time in seconds to AiO2 from 90 to 40%	baseline	Time in seconds to AiO2 from 90 to 40% after activating laser mode on the monsoon jet ventilator.

Secondary Outcome Measures

Name	Time	Method
Differences in time to laser mode AiO2	baseline	Differences in time to laser mode AiO2 between trachea and left and right mainstem bronchi.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States