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Oxygen Insufflation Via Flexible Scope

Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06680648
Acronym
OxyInsuffl
Enrollment
64
Registered
2024-11-08
Start date
2024-11-30
Completion date
2024-12-31
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Management When Secretions Obstruct the Larynx, Insertion of a Flexible Bronchoscope

Keywords

Flaxible Scope guided intubation, Fibreoptic intubation, The bleeding airway, The difficult airway

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

Interventions

PROCEDUREaddition 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

PROCEDUREno-oxygen insufflation

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

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

one arm is oxygen insufflation first followed by no-insufflation the second arm is: no insufflation followed by oxygen insufflation

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Anesthesiologists attending the airway course Airwaymanagement for Anaesthesiologists \-

Exclusion criteria

* non acceptance of participation

Design outcomes

Primary

MeasureTime frameDescription
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 advancement90 secondsThe fraction in whom The flexible scope is advanced to the trachea with maintained visibility all the time until vocal cord is seen

Secondary

MeasureTime frameDescription
Duration until the tip of the scope is in the trachea0-2 minutesTime from the tip of the scope passes the teeth until it is in the trachea
The scope is advanced to the trachea within 2 minutes2 minutesThe flexible scope is advanced to the trachea with or without maintained visibility
Operation percieved ease of advancing the scope to the trachea with maintained visibility2 minutesOperation percieved ease of advancing the scope to the trachea with maintained visibility, on a visual analogue scale from 1-10, 1 = very easy, 10 = almost impossible, lowest is best
Operation percieved ease of advancing the scope to the trachea, overall2 minuteOperation percieved ease of advancing the scope to the trachea overall, , on a visual analogue scale from 1-10, 1 = very easy, 10 = almost impossible, lower score is best.
The scope is advanced to the trachea within 1 minute1 minuteThe flexible scope is advanced to the trachea with or without maintained visibility
unobstructed advancement to the trachea in 90 seconds90 secondsThe flexible scope is advanced to the trachea with maintained visibility
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds30 sekundsThe fraction of participants in each group who obtain a view of vocal cord(s) without the view being obstructed at any point
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute1 minuteThe fraction of participants in each group who obtain a view of the vocal cord(s) without the view being obstructed at any point
Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds90 secondsThe fraction of particip in each group who obtain a view of the vocal cord(s) without the view being obstructed, Obtained in 90 seconds
The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute1 minuteThe fraction of the attempts when the flexible scope is advanced to the trachea with maintained visibility
unobstructed advancement to the trachea in two minutes2 minuteThe flexible scope is advanced to the trachea with maintained visibility

Other

MeasureTime frameDescription
Operator pecieved benefit of the addition of oxygen insufflation2 minutesAfter having tried the technique, the operator answers the question: How do you find that the addition of oxygen affects the advancement of the scope to the trachea? The aswer is on a VAS (Visual Analogue Scale) sale form -5 = It makes it much worse via 0 = neutral to +5 (it makes it much better), higher is best

Countries

Denmark

Contacts

Primary ContactMichael S Kristensen, MD
michael.seltz.kristensen@regionh.dk+4535458033

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026