Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2019-05-01
2020-01-06
Brief Summary
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Detailed Description
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Infrared light is applied to the front of the neck of patients for awake flexible optical intubation. The infrared light can be detected by the camera at the tip of the flexible video-bronchoscope. The flexible scope is introduced into the trachea with or without the aid of the blinking infra red light and the ease of placement of the flexible scope is studied.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Infrared guidance first
In this arm the infra red guidance is applied to the first passage of the flexible scope to the trachea.
The second passage of the flexible scope is without the infrared light
Tracheal intubation by endoscopy with flexible bronchoscope
A blinking infrared light source is placed on the anterior neck at the level of the cricothyroid membrane to serve as a guide to facilitate finding the way to the trachea
Infrared guidance last
In this arm NO infra red guidance is applied to the first passage of the flexible scope to the trachea.
The second passage of the flexible scope is with the infrared light as guide
Tracheal intubation by endoscopy with flexible bronchoscope
A blinking infrared light source is placed on the anterior neck at the level of the cricothyroid membrane to serve as a guide to facilitate finding the way to the trachea
Interventions
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Tracheal intubation by endoscopy with flexible bronchoscope
A blinking infrared light source is placed on the anterior neck at the level of the cricothyroid membrane to serve as a guide to facilitate finding the way to the trachea
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients at high risk of aspiration of gastric content
* Patients with hypoxia, saturation \< 90 % on ambient air
* Patients with audible stridor at rest
* American Society of Anesthesiology (ASA) physical class \> 3
* contraindication for trans-crico-thyoid-membrane puncture (cancer, infection on the site, severely coagulopathies, inability to identify the crico-thyroid membrane)
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Michael Seltz Kristensen
Principal Investigator
Principal Investigators
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Michael S Kristensen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, , Denmark
Countries
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References
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Kristensen MS, Hesselfeldt R, Brinkenfeldt HK, Biro P. Infrared flashing light through the cricothyroid membrane as guidance to awake intubation with a flexible bronchoscope: A randomised cross-over study. Acta Anaesthesiol Scand. 2023 Apr;67(4):432-439. doi: 10.1111/aas.14204. Epub 2023 Feb 2.
Other Identifiers
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H-18038322 IRRIS
Identifier Type: -
Identifier Source: org_study_id
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