Clinical trial NCT03234283: Visualization of the Intubation Pathway With the "IRRIS"-Device
Official title: Video-laryngoscopic Visualization of the Intubation Pathway With the "IRRIS"-Device. A Clinical Safety and Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Keywords: Intubation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, open label, non-randomized, safety and feasibility study.
Primary purpose: OTHER

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 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients scheduled for elective surgery requiring general anesthesia and tracheal intubation.
2. Patient age: adult (\>18 years old)
3. Mallampati scores 1 to 3.
4. ASA Physical Status Classification System 1-3
5. Ability to understand the requirements of the study, willingness to comply with its instructions and schedules, and agreement to the informed consent

Exclusion Criteria:

1. Emergency cases
2. Expected airway difficulties as defined during the pre-anaesthesia visit
3. Necessity for an alternative airway management approach other than by using a video-laryngoscope
4. Rapid sequence induction
5. Skin disorders and skin light sensitivity (SLE, lupus, Porphyria, Dermatomyositis, Pemphigus, Pellagra etc.)
6. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
7. Impaired head and neck mobility
8. Scars or skin injuries at the neck

Primary outcomes:
measure: Safety 1: Absence of skin lesions
timeFrame: 15 minutes after end of anesthesia
measure: Safety 2: Severity of skin lesions
timeFrame: 15 minutes after end of anesthesia
Secondary outcomes:
measure: Proof of Concept 2: Intubation success
timeFrame: 5 minutes after start of intubation
measure: Proof of Concept 3: Intubation success
timeFrame: 5 minutes after start of intubation
measure: Proof of Concept 4: Intubation success
timeFrame: 5 minutes after start of intubation
measure: Proof of Concept 5: Ease of use of IRRIS
timeFrame: 5 minutes after start of intubation
measure: Proof of Concept 7: Ease of use of IRRIS
timeFrame: 5 minutes after start of intubation
measure: Proof of Concept 8: Intubation success
timeFrame: 5 minutes after start of intubation
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institue of Anesthesiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Institue of Anesthesiology
name: Peter Biro, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20.
citation: Howard-Quijano KJ, Huang YM, Matevosian R, Kaplan MB, Steadman RH. Video-assisted instruction improves the success rate for tracheal intubation by novices. Br J Anaesth. 2008 Oct;101(4):568-72. doi: 10.1093/bja/aen211. Epub 2008 Aug 1.
citation: Song Y, Oh J, Chee Y, Lim T, Kang H, Cho Y. A novel method to position an endotracheal tube at the correct depth using an infrared sensor stylet. Can J Anaesth. 2013 May;60(5):444-9. doi: 10.1007/s12630-013-9898-6. Epub 2013 Feb 1.
citation: El-Sayed IH, Ho JE, Eisele DW. External light guidance for percutaneous dilatational tracheotomy. Head Neck. 2011 Aug;33(8):1206-9. doi: 10.1002/hed.21610. Epub 2011 Mar 16.
citation: Kaplan MB, Ward D, Hagberg CA, Berci G, Hagiike M. Seeing is believing: the importance of video laryngoscopy in teaching and in managing the difficult airway. Surg Endosc. 2006 Apr;20 Suppl 2:S479-83. doi: 10.1007/s00464-006-0038-z. Epub 2006 Mar 16.