Status:
COMPLETED
Visualization of the Intubation Pathway With the "IRRIS"-Device
Lead Sponsor:
University of Zurich
Conditions:
Difficult Intubation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, open label, non-randomized, single centre safety and feasibility study. Patients with no expected airway difficulties scheduled for elective surgery including tracheal intubation and ge...
Detailed Description
The IRRIS (InfraRed - Red Intubation System) is an external disposable light source in a patch that is intended for single use while it is placed externally on the patient's neck before tracheal intub...
Eligibility Criteria
Inclusion
- Male and female patients scheduled for elective surgery requiring general anesthesia and tracheal intubation.
- Patient age: adult (\>18 years old)
- Mallampati scores 1 to 3.
- ASA Physical Status Classification System 1-3
- Ability to understand the requirements of the study, willingness to comply with its instructions and schedules, and agreement to the informed consent
Exclusion
- Emergency cases
- Expected airway difficulties as defined during the pre-anaesthesia visit
- Necessity for an alternative airway management approach other than by using a video-laryngoscope
- Rapid sequence induction
- Skin disorders and skin light sensitivity (SLE, lupus, Porphyria, Dermatomyositis, Pemphigus, Pellagra etc.)
- Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
- Impaired head and neck mobility
- Scars or skin injuries at the neck
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03234283
Start Date
July 1 2017
End Date
November 14 2017
Last Update
November 17 2017
Active Locations (1)
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1
University Hospital Zurich, Institue of Anesthesiology
Zurich, Canton of Zurich, Switzerland, 8091