Condition category
Surgery
Date applied
06/08/2019
Date assigned
17/08/2019
Last edited
06/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
All anaesthesia requires the safe provision of oxygen and anaesthesia gases. These are delivered through a tube called an endotracheal tube, which is placed by the anaesthetist in the patient's windpipe (trachea). This at times can be unexpectedly difficult to do. A fiberoptic camera can be used to place this tube when difficulty arises or is anticipated. All anaesthetists need to be trained to be able to use a fiberoptic camera. Infrequent use of this technique can make it challenging for anaesthetists. The infrared red intubation system (IRRIS) may make the use of fiberoptic camera and the insertion of the breathing tube in airway less difficult and in doing so may decrease any potential harm to the patient. IRRIS is a small device which is placed on the throat. The device emits an infrared light which can be visualized inside the throat by a fibreoptic camera. It is thought to be a useful device in that it may aid fibreoptic intubation in both difficult and normal airways. This study will determine if the IRRIS device will make it easier for the anaesthetists to place the breathing tube in the windpipe and determine if this device should be used routinely by all anaesthetists.

Who can participate?
Patients over the age of 18 who require general anaesthesia and tracheal intubation for the surgical procedure can participate in the study.

What does the study involve?
Patients will be randomly assigned to receive the intubation process as normal or with the addition of the IRRIS device. The surgical procedure and follow-up will proceed as normal for all patients.

What are the possible benefits and risks of participating?
Potential benefits:
1. The IRRIS device may assist in identifying glottic opening in a quicker time so reducing the risk of potential hypoxia in a critical situation.
2. It may assist in increasing the confidence of using the fiberoptic scope among anaesthetists.
3. It may result in less trauma to the airway when the fiberoptic scope is being used.
Potential risk:
Trauma to the airway can occur as a result of the administration of general anaesthesia, this would be a risk with or without use of fiberoptic scope.

Where is the study run from?
Beaumont Hospital, Ireland

When is the study starting and how long is it expected to run for?
January to June 2019

Who is funding the study?
Beaumont Hospital, Ireland

Who is the main contact?
1. Dr Chandar Maheshwari
chandar.maheshwari@cuh.ie
2. Dr Michael Moore
michaelmoore2@beaumont.ie
3. Dr Edel Duggan
edelduggan@beaumont.ie

Trial website

Contact information

Type

Public

Primary contact

Dr Chandar Maheshwari

ORCID ID

http://orcid.org/0000-0002-6250-3864

Contact details

Temple Street Hospital
Temple Street
Dublin
D01 YC67
Ireland
00353 1 809 2773
chandar.maheshwari@cuh.ie

Type

Public

Additional contact

Dr Michael Moore

ORCID ID

Contact details

Department of anaesthesia
Beaumont Hospital
Dublin 9
Dublin
1297
Ireland
00353 1 809 2773
michaelmoore2@beaumont.ie

Type

Public

Additional contact

Dr Edel Duggan

ORCID ID

Contact details

Department of anaesthesia
Beaumont Hospital
Dublin 9
Dublin
1297
Ireland
00353 1 809 2773
edelduggan@beaumont.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

001

Study information

Scientific title

Does the infrared red intubation system (IRRIS) improve the fiberoptic intubation conditions? A randomized control trial

Acronym

Study hypothesis

The Infrared Red Intubation System (IRRIS) improves the fibreoptic intubation conditions

Ethics approval

Approved 31/12/2018, Beaumont Hospital Ethics (Medical and Research) Committee (Beaumont Hospital, Beaumont Road, Dublin 9, Ireland; 00 353 1 809 2680;beaumontethics@rcsi.com), ref: 18/56

Study design

Interventional single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional file (ISRCTN88166769)

Condition

Difficult Intubation

Intervention

Patients were randomly allocated to intervention (intubation with IRRIS) and controls (intubation without IRRIS) (sealed envelope technique).

Both study arms received the same predefined standardised anaesthesia technique/ treatment ie fentanyl 2 µg/kg I.V induction was done with propofol target-controlled infusion (TCI) with target plasma concentration (CPT) between 4 to 6 mg/ml. After achieving BIS value between 40 to 60, all patients were manually ventilated with face mask 100% oxygen. Neuromuscular blocking agent (Vacronium 0.15 mg/kg I.V.) was administered after checking adequacy of mask ventilation.

In the intervention group, the IRRIS was attached to the patient's neck skin just beneath the laryngeal prominence (Adam's apple).
After the onset of neuromuscular block confirmed by using neuromuscular monitoring, fiberoptic bronchoscopy (FOB) was performed by the primary investigator. Theatre staff who was not involved in the study monitoring the time of FOB with a stopwatch.

Intervention type

Device

Phase

Not Applicable

Drug names

Infrared intubation system (IRRIS)

Primary outcome measure

Time in seconds from when the point of the fiberoptic bronchoscope (FOB) is inserted in the mouth until it passes through the glottis, measured by using a stopwatch

Secondary outcome measures

1. Number of fiberoptic intubation attempts needed until successful intubation
2. Manoeuvres (head tilt, chin lift, jaw thrust and lingual traction) used to aid intubation

Overall trial start date

15/07/2018

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age >18 years old
2. Patients requiring general anaesthesia
3. Malampatti 1 and 2
4. ASA Physical Status Classification System 1and 2
5. Full capacity of giving informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58

Participant exclusion criteria

1. History of difficult intubation
2. Emergency surgery
3. BMI > 35 kg/ m2
4. Known anatomical anomalies of the airway
5. Pregnant

Recruitment start date

01/01/2019

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Anaesthesia
Beaumont Hospital Beaumont Road Dublin 9
Dublin
1297
Ireland

Sponsor information

Organisation

Beaumont Hospital

Sponsor details

Beaumont Hospital
Beaumont Road
Dublin
1297
Ireland
00353 1 809 2773
michaelmoore2@beaumont.ie

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Beaumont Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/01/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/09/2019: Participant information sheet uploaded.