Visualization of the Intubation Pathway With the IRRIS-Device

Study Overview
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Brief Summary
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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 general anesthesia procedures will be enrolled into the study. Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a light that penetrates through the skin into the airway and that is visible on the video-laryngoscope display. This light highlights the right pathway for the tracheal tube and facilitates the visual recognition and identification of the laryngeal inlet. In case of problems identified during the induction period such as an unexpected difficult intubation situation and the IRRIS does not provide the expected facilitation of intubation, the local unexpected difficult airway protocol goes into effect.

Detailed Description
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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 intubation for the duration of tracheal intubation. The device transmits near-infrared light through the skin towards the trachea. During laryngoscopy, the emitted light becomes visible only from the trachea and not from the oesophagus. Video assisted devices which already are in the market known as video-laryngoscopes and fiberoptic bronchoscopes are capable of detecting and visualizing the emitted light so that the anaesthesiologist who is performing the intubation is aided to direct and insert the endotracheal tube into the trachea by following the light on the screen of his video-assisted endoscope. The objective of this study is to assess the safety, and performance of IRRIS in patients who undergo tracheal intubation in terms of skin integrity, duration of intubation, number of attempts, success of intubation and usability aspects in terms of subjective physician grading of the IRRIS.

Official Title
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Video-laryngoscopic Visualization of the Intubation Pathway With the IRRIS-Device. A Clinical Safety and Proof of Concept Study

Conditions
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Difficult Intubation

Intervention / Treatment
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* Device: IRRIS InfraRed - Red Intubation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, open label, non-randomized, safety and feasibility study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study intervention group<br>All participants will be intubated with a video-laryngiscope by guiding the tracheal tube according to the highlighted Larynx on the Video Screen. | Device: IRRIS InfraRed - Red Intubation System<br>* IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence. Tracheal intubation will be performed by using a video-laryngoscope in a standardized Fashion and by guiding the tracheal tube into the Larynx by following the visual Signal on the Screen that is caused by IRRIS. The handling of IRRIS and the Performance of tracheal Intubation will be recorded. Patients will be monitored for safety parameters and possible adverse events during the study until recovered and released from the postoperative care unit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety 1: Absence of skin lesions | skin lesions, irritations after removal of the patch at the end of anesthesia (yes / no) | 15 minutes after end of anesthesia | 
| Safety 2: Severity of skin lesions | skin lesions, irritations after removal of the patch at the end of anesthesia (mild/moderate/severe) | 15 minutes after end of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proof of Concept 2: Intubation success | Successful video-laryngoscopic tracheal intubation | 5 minutes after start of intubation | 
| Proof of Concept 3: Intubation success | Duration of intubation (time in seconds from inserting the video laryngoscope till tracheal tube cuff inflation) | 5 minutes after start of intubation | 
| Proof of Concept 4: Intubation success | Number of video laryngoscopy attempts till successful tracheal tube placement (number of video laryngoscope insertions during an intubation process that are related to the IRRIS operation) | 5 minutes after start of intubation | 
| Proof of Concept 5: Ease of use of IRRIS | Subjective degree of difficulty of the entire intubation process according a Verbal Rating Scale (VRS) assessed by the intubation person (values from 1 = very easy to 10 = extremely difficult) | 5 minutes after start of intubation | 
| Proof of Concept 7: Ease of use of IRRIS | Subjective degree of helpfulness of the visual aid by the device: according a Verbal Rating Scale (VRS) assessed by the intubation person (values from 1 = not helpful at all to 10 = very helpful) | 5 minutes after start of intubation | 
| Proof of Concept 8: Intubation success | Failures: necessity of alternative airway securing or abort of tracheal intubation if initial attempt(s) with IRRIS failed. (yes / no and number and choice of alternative techniques) | 5 minutes after start of intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation