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

NCT ID: NCT03234283

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-11-14

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.

Conditions

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Difficult Intubation

Keywords

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Intubation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, open label, non-randomized, safety and feasibility study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IRRIS InfraRed - Red Intubation System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Biro, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Institue of Anesthesiology

Locations

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University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 28219617 (View on PubMed)

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.

Reference Type RESULT
PMID: 25533140 (View on PubMed)

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.

Reference Type RESULT
PMID: 18676418 (View on PubMed)

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.

Reference Type RESULT
PMID: 23370979 (View on PubMed)

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.

Reference Type RESULT
PMID: 21413098 (View on PubMed)

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.

Reference Type RESULT
PMID: 16544062 (View on PubMed)

Other Identifiers

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2016-01657

Identifier Type: -

Identifier Source: org_study_id