Oxygen Insufflation Via Flexible Scope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: addition of oxygeninsufflation via working channel of flexible scope, no-oxygen insufflation.
- Who it may be relevant to
- Registry conditions: Insertion of a Flexible Bronchoscope, Airway Management When Secretions Obstruct the Larynx. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea
Overview
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
Interventions
- Procedure 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 - Procedure no-oxygen insufflation
no-oxygen insufflation added to the flexible scope while advancing it
Primary outcome measures
- 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 [Time frame: 90 seconds]
Secondary outcome measures (11)
- The scope is advanced to the trachea within 2 minutes [Time frame: 2 minutes]
- Duration until the tip of the scope is in the trachea [Time frame: 0-2 minutes]
- Operation percieved ease of advancing the scope to the trachea with maintained visibility [Time frame: 2 minutes]
- Operation percieved ease of advancing the scope to the trachea, overall [Time frame: 2 minute]
- The scope is advanced to the trachea within 1 minute [Time frame: 1 minute]
- unobstructed advancement to the trachea in two minutes [Time frame: 2 minute]
- unobstructed advancement to the trachea in 90 seconds [Time frame: 90 seconds]
- Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds [Time frame: 30 sekunds]
- Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute [Time frame: 1 minute]
- Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds [Time frame: 90 seconds]
- The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute [Time frame: 1 minute]
Eligibility criteria
Inclusion criteria
Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"
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Exclusion criteria
- non acceptance of participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet, Unoversity Hospital of Copenhagen — Copenhagen
Publications
- 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. PMID 39469423
Identifiers
NCT: NCT06680648 · OxygenInsufflation_F-24066560