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Oxygen Insufflation Via Flexible Scope

NCT ID: NCT06680648

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Insufflation first followed by no-insufflation

Group Type EXPERIMENTAL

addition of oxygeninsufflation via working channel of flexible scope

Intervention Type PROCEDURE

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

no-insufflation first followed by insufflation

Group Type ACTIVE_COMPARATOR

no-oxygen insufflation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

no-oxygen insufflation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

\-

Exclusion Criteria

* non acceptance of participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Michael Seltz Kristensen

Consultant anaesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet, Unoversity Hospital of Copenhagen

Copenhagen, The Capital Region, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Michael S Kristensen, MD

Role: CONTACT

[email protected]
+4535458033

Facility Contacts

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Michael S Kristensen, MD

Role: primary

[email protected]
0045 21711702

Marianne Hjorth

Role: backup

[email protected]
0045 35453474

References

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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.

Reference Type BACKGROUND
PMID: 39469423 (View on PubMed)

Other Identifiers

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OxygenInsufflation_F-24066560

Identifier Type: -

Identifier Source: org_study_id

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