Skip to main content
OpenTrials
Completed

NCT Number: NCT03234283

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Difficult Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Institue of Anesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety 1: Absence of skin lesions

    Time frame: 15 minutes after end of anesthesia

    skin lesions, irritations after removal of the patch at the end of anesthesia (yes / no)

  2. Safety 2: Severity of skin lesions

    Time frame: 15 minutes after end of anesthesia

    skin lesions, irritations after removal of the patch at the end of anesthesia (mild/moderate/severe)

Secondary outcomes

  1. Proof of Concept 2: Intubation success

    Time frame: 5 minutes after start of intubation

    Successful video-laryngoscopic tracheal intubation

  2. Proof of Concept 3: Intubation success

    Time frame: 5 minutes after start of intubation

    Duration of intubation (time in seconds from inserting the video laryngoscope till tracheal tube cuff inflation)

  3. Proof of Concept 4: Intubation success

    Time frame: 5 minutes after start of intubation

    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)

  4. Proof of Concept 5: Ease of use of IRRIS

    Time frame: 5 minutes after start of intubation

    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. Proof of Concept 7: Ease of use of IRRIS

    Time frame: 5 minutes after start of intubation

    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)

  6. Proof of Concept 8: Intubation success

    Time frame: 5 minutes after start of intubation

    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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: IRRIS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.