Clinical trial NCT06680648: Oxygen Insufflation Via Flexible Scope
Official title: Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insertion of a Flexible Bronchoscope
Airway Management When Secretions Obstruct the Larynx
Keywords: Flaxible Scope guided intubation
Fibreoptic intubation
The bleeding airway
The difficult airway
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: one arm is oxygen insufflation first followed by no-insufflation the second arm is: no insufflation followed by oxygen insufflation
Primary purpose: TREATMENT

Brief 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

Detailed description: 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 criteria: Inclusion Criteria:

Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

-

Exclusion Criteria:

* non acceptance of participation

Primary outcomes:
measure: 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
Secondary outcomes:
measure: The scope is advanced to the trachea within 2 minutes
timeFrame: 2 minutes
measure: Duration until the tip of the scope is in the trachea
timeFrame: 0-2 minutes
measure: Operation percieved ease of advancing the scope to the trachea with maintained visibility
timeFrame: 2 minutes
measure: Operation percieved ease of advancing the scope to the trachea, overall
timeFrame: 2 minute
measure: The scope is advanced to the trachea within 1 minute
timeFrame: 1 minute
measure: unobstructed advancement to the trachea in two minutes
timeFrame: 2 minute
measure: unobstructed advancement to the trachea in 90 seconds
timeFrame: 90 seconds
measure: Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds
timeFrame: 30 sekunds
measure: Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute
timeFrame: 1 minute
measure: Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds
timeFrame: 90 seconds
measure: The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute
timeFrame: 1 minute
Other outcomes:
measure: Operator pecieved benefit of the addition of oxygen insufflation
timeFrame: 2 minutes
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Unoversity Hospital of Copenhagen
state: The Capital Region
Study officials:
References:
citation: Garioud A, Kristensen MS. Oxygen insufflation via the working channel during tracheal intubation guided by a flexible optical scope and benefits, dangers, and future of the method: a narrative review. BJA Open. 2024 Oct 17;12:100346. doi: 10.1016/j.bjao.2024.100346. eCollection 2024 Dec.