Not Yet RecruitingNot Applicable

Oxygen Insufflation Via Flexible Scope

Denmark64 participantsStarted 2024-11

Plain-language summary

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists" \- Exclusion Criteria: * non acceptance of participation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement

Timeframe: 90 seconds

Trial details

NCT IDNCT06680648

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Michael S Kristensen, MD

+4535458033 michael.seltz.kristensen@regionh.dk

View on ClinicalTrials.gov More Insertion of a Flexible Bronchoscope trials