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
- ISRCTN88166769.pdf Uploaded 06/09/2019