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Starting soon Not applicable

Oxygen Insufflation Via Flexible Scope

NCT06680648 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-11
Last updated
2024-11-14

Condition(s) studied

Insertion of a Flexible BronchoscopeAirway Management When Secretions Obstruct the Larynx

Investigational drug(s) / intervention(s)

addition of oxygeninsufflation via working channel of flexible scopeno-oxygen insufflation

addition of oxygeninsufflation via working channel of flexible scope: addition of oxygeninsufflation via working channel of flexible scope in order to improve visibility when advancing the flexible scope

no-oxygen insufflation: no-oxygen insufflation added to the flexible scope while advancing it

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists" \- Exclusion Criteria: * non acceptance of participation

Primary outcome measure(s)

  • 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 — 90 seconds
    The fraction in whom The flexible scope is advanced to the trachea with maintained visibility all the time until vocal cord is seen

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet, Unoversity Hospital of Copenhagen Copenhagen The Capital Region
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680648 on ClinicalTrials.gov ↗ ← All trials in Denmark