Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KEK 247/09
Study information
Scientific title
Comparison of the semi-flexible fiberscope SensaScope® and the rigid Bonfils® for intubation in simulated difficult airway: a randomized controlled trial
Acronym
BoSS
Study hypothesis
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
Bern Cantonal Ethics Commission [Kantonale Ethikkommission Bern], 22/02/2010, ref: KEK 247/09
Study design
Prospective randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Intubation success rate
Secondary outcome measures
1. Time necessary for intubation
2. Side effects
Overall trial start date
01/06/2011
Overall trial end date
01/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. 18 years of age
2. Elective surgery in general anesthesia requiring endotracheal intubation
3. Informed consent given
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant 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
Recruitment start date
01/06/2011
Recruitment end date
01/07/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Inselspital
Bern
CH-3011
Switzerland
Sponsor information
Organisation
University of Bern (Switzerland)
Sponsor details
Department of Anesthesiology and Pain Therapy
Murtenstrasse
Inselspital
Bern
CH-3011
Switzerland
-
robert.greif@insel.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Inselspital Bern (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary