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NCT Number: NCT06680648

Oxygen Insufflation Via Flexible Scope

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

-

Exclusion criteria

  • non acceptance of participation

Treatment and study plan

addition of oxygeninsufflation via working channel of flexible scope

Procedure

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

no-oxygen insufflation

Procedure

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

Primary outcomes

  1. 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

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

Secondary outcomes

  1. The scope is advanced to the trachea within 2 minutes

    Time frame: 2 minutes

    The flexible scope is advanced to the trachea with or without maintained visibility

  2. Duration until the tip of the scope is in the trachea

    Time frame: 0-2 minutes

    Time from the tip of the scope passes the teeth until it is in the trachea

  3. 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 with maintained visibility, on a visual analogue scale from 1-10, 1 = very easy, 10 = almost impossible, lowest is best

  4. Operation percieved ease of advancing the scope to the trachea, overall

    Time frame: 2 minute

    Operation 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.

  5. The scope is advanced to the trachea within 1 minute

    Time frame: 1 minute

    The flexible scope is advanced to the trachea with or without maintained visibility

  6. unobstructed advancement to the trachea in two minutes

    Time frame: 2 minute

    The flexible scope is advanced to the trachea with maintained visibility

  7. unobstructed advancement to the trachea in 90 seconds

    Time frame: 90 seconds

    The flexible scope is advanced to the trachea with maintained visibility

  8. Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds

    Time frame: 30 sekunds

    The fraction of participants in each group who obtain a view of vocal cord(s) without the view being obstructed at any point

  9. Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute

    Time frame: 1 minute

    The fraction of participants in each group who obtain a view of the vocal cord(s) without the view being obstructed at any point

  10. Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds

    Time frame: 90 seconds

    The fraction of particip in each group who obtain a view of the vocal cord(s) without the view being obstructed, Obtained in 90 seconds

  11. The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute

    Time frame: 1 minute

    The fraction of the attempts when the flexible scope is advanced to the trachea with maintained visibility

Other outcomes

  1. Operator pecieved benefit of the addition of oxygen insufflation

    Time frame: 2 minutes

    After 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael S Kristensen, MD

CONTACT

[email protected]

+4535458033

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: OxyInsuffl

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.