Central Airway ObstructionNCT05881863
To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation
An observational study of Central Airway Obstruction, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Airway Obstruction
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Candace Nelson contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Pankhura Gupta, 763-268-9823, gupta359@umn.edu
About this study
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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
Differences in time to laser mode AiO2
Differences in time to laser mode AiO2 between trachea and left and right mainstem bronchi.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start12 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Airway ObstructionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sudarshan Setty, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881863
- Sponsor's protocol ID
- ANES-2022-31377
- Status last verified
- Jan 2026
- First submitted
- 19 May 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation
- ClinicalTrials.gov ID
- NCT05881863
- Acronym / sponsor ID
- ANES-2022-31377
- Conditions
- Central Airway Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study | Other | – |
Primary outcome
Time in seconds to AiO2 from 90 to 40%
Time frame: baseline
Time in seconds to AiO2 from 90 to 40% after activating laser mode on the monsoon jet ventilator.
1 secondary outcome
Differences in time to laser mode AiO2
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Candace Nelson contact
Sudarshan Setty, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Airway Obstruction, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candace Nelson (nelso377@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in seconds to AiO2 from 90 to 40% (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.