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

NCT03234283 | Completed

• 1 other identifier: 2016-01657
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Intubation

Keywords

Intubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Proof of Concept 2: Intubation success

  5 minutes after start of intubation

• Proof of Concept 3: Intubation success

  5 minutes after start of intubation

• Proof of Concept 4: Intubation success

  5 minutes after start of intubation

• Proof of Concept 5: Ease of use of IRRIS

  5 minutes after start of intubation

• Proof of Concept 7: Ease of use of IRRIS

  5 minutes after start of intubation

Study Arms (1)

Study intervention group

EXPERIMENTAL

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

Interventions

IRRIS InfraRed - Red Intubation System DEVICE

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.

Study intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 28219617 RESULT

• 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.

  PMID: 25533140 RESULT

• 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.

  PMID: 18676418 RESULT

• 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.

  PMID: 23370979 RESULT

• 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.

  PMID: 21413098 RESULT

• 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.

  PMID: 16544062 RESULT

Study Officials

• Peter Biro, MD

  University Hospital Zurich, Institue of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, open label, non-randomized, safety and feasibility study.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: July 31, 2017
• Study Start: July 1, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)