Comparison of the semi-flexible fiberscope SensaScope® and the rigid Bonfils® for intubation in simulated difficult airway
| ISRCTN | ISRCTN14429285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14429285 |
| Secondary identifying numbers | KEK 247/09 |
- Submission date
- 28/09/2011
- Registration date
- 19/10/2011
- Last edited
- 20/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Endotracheal intubation is a medical procedure that is performed when a patient cannot breathe on their own. A tube is placed into their windpipe through their mouth or nose. Bonfils and SensaScope are two devices used in endotracheal intubation that both have a good success rate in normal conditions. However, their success rate in difficult intubation conditions is not known. The aim of this study is to compare those two devices when used on patients scheduled for elective surgery who require general anesthestic with endotracheal intubation.
Who can participate?
Patients aged over 18 who choose to have surgery (elective surgery) requiring general anesthestic and endotracheal intubation
What does the study involve?
Participants wear a stiff collar around their neck that mimics difficult intubation conditions and limits mouth opening. Participants are randomly allocated to be intubated using either the Bonfils or the SensaScope. Intubation success rate, time necessary for intubation and side effects are assessed. The collar is removed after intubation or in case of failure of the devices.
What are the possible benefits and risks of participating?
There are no benefits and no specific risks involved. No more side effects are expected than with normal endotracheal intubation. If the device fails, the stiff collar can be removed.
Where is the study run from?
University Hospital Inselspital Bern (Switzerland)
When is the study starting and how long is it expected to run for?
June 2011 to July 2012
Who is funding the study?
University Hospital Inselspital Bern (Switzerland)
Who is the main contact?
Prof. Robert Greif
Contact information
Scientific
Department of Anesthesiology and Pain Therapy
Murtenstrasse
Inselspital
Bern
CH-3011
Switzerland
Study information
| Study design | Prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparison of the semi-flexible fiberscope SensaScope® and the rigid Bonfils® for intubation in simulated difficult airway: a randomized controlled trial |
| Study acronym | BoSS |
| Study objectives | The Bonfils®, compared to the SensaScope®, has a 15% higher failure rate of tracheal intubation in this simulated difficult airway scenario. H0 = Success rate Bonfils® success rate SensaScope® ≤ 15% (difference). Alternative hypothesis H1 = Success rate Bonfils® success rate SensaScope® >15% difference. Additionally, learning curves for both devices will be established. |
| Ethics approval(s) | Bern Cantonal Ethics Commission [Kantonale Ethikkommission Bern], 22/02/2010, ref: KEK 247/09 |
| Health condition(s) or problem(s) studied | Perioperative airway management |
| Intervention | The patients will receive a stiff collar around their neck befor intubation to stabilize the neck and reduce mouth opening (simulation of a difficult airway). Patients will be randomly assigned to the either being intubated with the Bonfils® or with the SensaScope®. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Intubation success rate |
| Secondary outcome measures | 1. Time necessary for intubation 2. Side effects |
| Overall study start date | 01/06/2011 |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Total final enrolment | 740 |
| Key inclusion criteria | 1. 18 years of age 2. Elective surgery in general anesthesia requiring endotracheal intubation 3. Informed consent given |
| Key exclusion criteria | 1. High risk of aspiration (non-fasted, massive gastroesophageal reflux disease) 2. Known difficult mask ventilation 3. Mouth opening < 20mm 4. Patients not speaking German or French 5. Refusing to participate |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
CH-3011
Switzerland
Sponsor information
Hospital/treatment centre
Department of Anesthesiology and Pain Therapy
Murtenstrasse
Inselspital
Bern
CH-3011
Switzerland
| robert.greif@insel.ch | |
| Website | http://www.insel.ch/ |
"ROR" |
https://ror.org/02k7v4d05 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/10/2020 | 20/10/2020 | Yes | No |
Editorial Notes
20/10/2020: Publication reference and total final enrolment number added.
15/09/2016: Plain English summary added.
