Oxygen Insufflation Via Flexible Scope (OxyInsuffl)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insertion of a Flexible Bronchoscope; Airway Management When Secretions Obstruct the Larynx
• Intervention / Treatment: Procedure: addition of oxygeninsufflation via working channel of flexible scope; Procedure: no-oxygen insufflation

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

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael S Kristensen, MD; Phone Number: +4535458033; Email: michael.seltz.kristensen@regionh.dk

Study Locations

• Denmark
  • The Capital Region
    • Copenhagen, The Capital Region, Denmark, 2100
      • Rigshospitalet, Unoversity Hospital of Copenhagen
      • Principal Investigator: Michael S Kristensen, MD
      • Contact: Michael S Kristensen, MD; Phone Number: 0045 21711702; Email: michael.seltz.kristensen@regionh.dk
      • Contact: Marianne Hjorth; Phone Number: 0045 35453474; Email: marianne.hjorth@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

-

Exclusion Criteria:

• non acceptance of participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insufflation first followed by no-insufflation	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
Active Comparator: no-insufflation first followed by insufflation	Procedure: no-oxygen insufflation; no-oxygen insufflation added to the flexible scope while advancing it

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The fraction in whom The flexible scope is advanced to the trachea with maintained visibility all the time until vocal cord is seen	90 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The scope is advanced to the trachea within 2 minutes	The flexible scope is advanced to the trachea with or without maintained visibility	2 minutes
Duration until the tip of the scope is in the trachea	Time from the tip of the scope passes the teeth until it is in the trachea	0-2 minutes
Operation percieved ease of advancing the scope to the trachea with maintained visibility	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	2 minutes
Operation percieved ease of advancing the scope to the trachea, overall	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.	2 minute
The scope is advanced to the trachea within 1 minute	The flexible scope is advanced to the trachea with or without maintained visibility	1 minute
unobstructed advancement to the trachea in two minutes	The flexible scope is advanced to the trachea with maintained visibility	2 minute
unobstructed advancement to the trachea in 90 seconds	The flexible scope is advanced to the trachea with maintained visibility	90 seconds
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds	The fraction of participants in each group who obtain a view of vocal cord(s) without the view being obstructed at any point	30 sekunds
Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one 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	1 minute
Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 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	90 seconds
The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute	The fraction of the attempts when the flexible scope is advanced to the trachea with maintained visibility	1 minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator pecieved benefit of the addition of oxygen insufflation	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	2 minutes

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Flaxible Scope guided intubation; Fibreoptic intubation; The bleeding airway; The difficult airway
• Other Study ID Numbers: OxygenInsufflation_F-24066560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No