Condition category
Respiratory
Date applied
28/09/2011
Date assigned
19/10/2011
Last edited
15/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Robert Greif

ORCID ID

Contact details

Department of Anesthesiology and Pain Therapy
Murtenstrasse
Inselspital
Bern
CH-3011
Switzerland

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

http://www.insel.ch/

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

Publication citations

Additional files

Editorial Notes

15/09/2016: Plain English summary added.