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

NCT05881863 | Recruiting

• 1 other identifier: ANES-2022-31377
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time in seconds to AiO2 from 90 to 40%

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

  baseline

Secondary Outcomes (1)

• Differences in time to laser mode AiO2

  baseline

Interventions

No intervention OTHER

This is an observational study

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

Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

• Sudarshan Setty, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Nelson

CONTACT

nelso377@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: January 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)