Infrared guided placement of a breathing tube before surgery
| ISRCTN | ISRCTN88166769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88166769 |
| Secondary identifying numbers | 001 |
- Submission date
- 06/08/2019
- Registration date
- 17/08/2019
- Last edited
- 07/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Temple Street Hospital
Temple Street
Dublin
D01 YC67
Ireland
 ORCID ID |
0000-0002-6250-3864 |
|---|---|
| Phone | 00353 1 809 2773 |
| chandar.maheshwari@cuh.ie |
Public
Department of anaesthesia
Beaumont Hospital
Dublin 9
Dublin
1297
Ireland
| Phone | 00353 1 809 2773 |
|---|---|
| michaelmoore2@beaumont.ie |
Public
Department of anaesthesia
Beaumont Hospital
Dublin 9
Dublin
1297
Ireland
| Phone | 00353 1 809 2773 |
|---|---|
| edelduggan@beaumont.ie |
Study information
| Study design | Interventional single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN88166769.pdf |
| Scientific title | Does the infrared red intubation system (IRRIS) improve the fiberoptic intubation conditions? A randomized control trial |
| Study objectives | The Infrared Red Intubation System (IRRIS) improves the fibreoptic intubation conditions |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/07/2018 |
| Completion date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 58 |
| Total final enrolment | 58 |
| Key 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. |
| Key exclusion criteria | 1. History of difficult intubation 2. Emergency surgery 3. BMI > 35 kg/ m2 4. Known anatomical anomalies of the airway 5. Pregnant |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 30/06/2019 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Beaumont Road
Dublin 9
Dublin
1297
Ireland
Sponsor information
Hospital/treatment centre
Beaumont Hospital
Beaumont Road
Dublin
1297
Ireland
| Phone | 00353 1 809 2773 |
|---|---|
| michaelmoore2@beaumont.ie | |
"ROR" |
https://ror.org/043mzjj67 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/09/2019 | No | Yes | ||
| Abstract results | 01/07/2020 | 07/09/2021 | No | No |
Additional files
- ISRCTN88166769.pdf
- Uploaded 06/09/2019
Editorial Notes
07/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
06/09/2019: Participant information sheet uploaded.
