AzTrials
AzTrials

Difficult IntubationIRRISNCT03234283

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

A study testing IRRIS InfraRed - Red Intubation System in people with Difficult Intubation, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Difficult Intubation
What is being tested?
IRRIS InfraRed - Red Intubation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSwitzerland
Study dates
1 Jul 2017to 14 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich, Institue of Anesthesiology

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
IRRIS InfraRed - Red Intubation System
Keywords
Intubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IRRIS InfraRed - Red Intubation SystemDevice

    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 groups in NCT03234283
Study groupRoleWhat they receive
Study intervention groupExperimentalAll participants will be intubated with a video-laryngiscope by guiding the tracheal tube according to the highlighted Larynx on the Video Screen.
Receives: Device: IRRIS InfraRed - Red Intubation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety 1: Absence of skin lesions

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

    Measured: 15 minutes after end of anesthesia

  2. Safety 2: Severity of skin lesions

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

    Measured: 15 minutes after end of anesthesia

Secondary outcomes (6)

  1. Proof of Concept 2: Intubation success

    Successful video-laryngoscopic tracheal intubation

    Measured: 5 minutes after start of intubation

  2. Proof of Concept 3: Intubation success

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

    Measured: 5 minutes after start of intubation

  3. 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)

    Measured: 5 minutes after start of intubation

  4. 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)

    Measured: 5 minutes after start of intubation

  5. 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)

    Measured: 5 minutes after start of intubation

  6. 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)

    Measured: 5 minutes after start of intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2017
  2. Study start1 Jul 2017
  3. Primary completion14 Nov 2017
  4. Study completion14 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
A prospective, open label, non-randomized, safety and feasibility study.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03234283
Sponsor's protocol ID
2016-01657
Other IDs
2016
Acronym
IRRIS
Status last verified
Nov 2017
First submitted
18 May 2017
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28219617

  • 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.

    PubMed 25533140

  • 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.

    PubMed 18676418

  • 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.

    PubMed 23370979

  • 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.

    PubMed 21413098

  • 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.

    PubMed 16544062

Questions about this trial

What is this clinical trial studying?

A study testing IRRIS InfraRed - Red Intubation System in people with Difficult Intubation, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety 1: Absence of skin lesions (time frame: 15 minutes after end of anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03234283, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in