Visualization of the Intubation Pathway With the "IRRIS"-Device (IRRIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Device: IRRIS InfraRed - Red Intubation System

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Institue of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study intervention group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Peter Biro, MD, University Hospital Zurich, Institue of Anesthesiology

Publications and helpful links

General Publications

• Goto Y, Goto T, Hagiwara Y, Tsugawa Y, Watase H, Okamoto H, Hasegawa K; Japanese Emergency Medicine Network Investigators. Techniques and outcomes of emergency airway management in Japan: An analysis of two multicentre prospective observational studies, 2010-2016. Resuscitation. 2017 May;114:14-20. doi: 10.1016/j.resuscitation.2017.02.009. Epub 2017 Feb 17.
• 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. Erratum In: Ann Emerg Med. 2017 May;69(5):540.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Intubation
• Other Study ID Numbers: 2016-01657

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