NCT05881863 To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation
| NCT ID | NCT05881863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Central Airway Obstruction |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-01-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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."
Eligibility Criteria
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
Contact & Investigator
Candace Nelson
✉ nelso377@umn.eduSudarshan Setty, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05881863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Central Airway Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05881863 currently recruiting?
Yes, NCT05881863 is actively recruiting participants. Contact the research team at nelso377@umn.edu for enrollment information.
Where is the NCT05881863 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05881863 clinical trial?
NCT05881863 is sponsored by University of Minnesota. The principal investigator is Sudarshan Setty, MD at University of Minnesota. The trial plans to enroll 50 participants.