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Trial registered on ANZCTR


Registration number
ACTRN12607000309482
Ethics application status
Not yet submitted
Date submitted
4/06/2007
Date registered
13/06/2007
Date last updated
13/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
OPTICAL STYLET INTUBATION: A COMPARISON OF THE BONFILS STYLET (RETROMOLAR APPROACH) WITH LEVITAN STYLET (MIDLINE APPROACH) FOR ROUTINE INTUBATION.
Scientific title
Optical stylet intubation: a comparison of intubation success rate of the Bonfils stylet (retromolar approach) with Levitan stylet (midline approach) for routine intubation.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Efficacy of routine intubation of elective surgical patients using fibreoptic stylet technology 1851 0
Condition category
Condition code
Surgery 1945 1945 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention-Intubation for elective surgery facilitated by optical stylet

Anaesthetists within the Department of Anaesthesia at Frankston Hospital without prior experience of optical stylet intubation will be randomly allocated to one of 2 groups: to learn intubation with the Bonfils (Group B) or to learn with the Levitan (Group L). Anesthetists will perform 20 intubations with their assigned device on succesive consented patients over a period of not more than 2 months. After 20 intubations with one device, the next 7 patients will be intubated via the alternative device. Washout period will be less than 14 days.
Intervention code [1] 1803 0
Treatment: Devices
Comparator / control treatment
Exposure-Bonfils optical stylet
Control-Levitan optical stylet
Control group
Active

Outcomes
Primary outcome [1] 2764 0
Intubation success rate. Following induction of anaesthesia up to 3 attempts at intubation will be permitted per patient. Oxygenation by bag and mask will be done between attempts. Failed intubations will be defined as inability to place the endotracheal tube in the trachea by 3 attempts.
Timepoint [1] 2764 0
At the end of intervention implementation.
Secondary outcome [1] 4656 0
1. Total time to acheive intubation (TTI).
Timepoint [1] 4656 0
A stopwatch will record the time from the insertion of the device into the oropharynx until the device is removed from the oral cavity. The TTI is the sum of the duration of all attempts (up to 3).
Secondary outcome [2] 4657 0
2. Anaesthetist rated intubation difficulty.
Timepoint [2] 4657 0
A 5-point Likert scale completed by anaesthetist after each patient.
Secondary outcome [3] 4658 0
3. Complications including patient sore throat, hoarse voice, dental trauma.
Timepoint [3] 4658 0
Measured during follow-up period in Post-Anaesthesia Care Unit.

Eligibility
Key inclusion criteria
Consented adult elective surgical patients with no anticipated airway difficulties (Mallampati scores 1-3)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or potential intubation difficulties, ASA status 4 or 5, emergency surgery and patients requiring a rapid sequence induction (severe gastro-oesophageal reflux, pregnancy etc)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled & consented by treating anaesthetist. Anaesthetist will have been allocated to group B or group L based on table of random numbers. Concealment will be via opaque envelopes. On opening envelope, anaesthetist will know if he/she will learn with the Bonfils (Group B) or Levitan (Group L) and therefore no longer be blinded. All anaesthetists will then undergo a standardized 1 hr training session for their device and practice on airway manikins. Patients will not be truly randomized in that if they fall in a particular anaesthetists operating list, they will be intubated according to that anaesthetists allocation (provided they are eligible to participate and agree).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Specialist anaesthetists will be assigned to either learn the Bonfils or Levitan optical stylet. 2 groups of anaesthetists will be generated via table of random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2088 0
Hospital
Name [1] 2088 0
Hospital funded study
Country [1] 2088 0
Primary sponsor type
Individual
Name
Dr Ashley Webb
Address
Country
Secondary sponsor category [1] 1893 0
Hospital
Name [1] 1893 0
Department of Anaesthesia, Frankston Hospital
Address [1] 1893 0
Country [1] 1893 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3878 0
Penisula Health ethics committee,
Ethics committee address [1] 3878 0
Ethics committee country [1] 3878 0
Australia
Date submitted for ethics approval [1] 3878 0
Approval date [1] 3878 0
Ethics approval number [1] 3878 0

Summary
Brief summary
Intubation is the insertion of an endotracheal tube into the trachea of an anaesthetized patient for airway management during surgery. Intubation is traditionally achieved by inserting a laryngoscope into the anaesthetized patient’s mouth, moving the tongue out of the way and inserting the endotracheal tube through the vocal cords if they can be seen. In the last decade there has been growing interest in a new type of intubating device called optical stylet. Optical stylets incorporate fiberoptic imaging elements in an intubation stylet design. Their appearance is of a thin semi-rigid telescope which an endotracheal tube is threaded over. While any patient may be intubated using a stylet, they have been particularly reccomended for difficult intubations, which occur with an incidence of between 1:300 and 1:3000 (rising with conditions such as obesity and sleep apnoea). The proposed study compares the ease of use and intubation success of the 2 optical stylets, the Bonfils (Storz, Germany) and the Levitan (Clarus, USA) (pictures) amongst specialist anaesthetists whose only experience with them was basic training with the device on airway mannikins. Both devices will be used according to their approved application for device entry at the Therapeutic Goods Administration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27906 0
Address 27906 0
Country 27906 0
Phone 27906 0
Fax 27906 0
Email 27906 0
Contact person for public queries
Name 10992 0
Dr Ashley Webb
Address 10992 0
Department of Anaesthesia
Frankston Hospital
Hastings Road
Frankston VIC 3199
Country 10992 0
Australia
Phone 10992 0
+61 3 97847445
Fax 10992 0
Email 10992 0
[email protected]
Contact person for scientific queries
Name 1920 0
Ashley Webb
Address 1920 0
Department of Anaesthesia
Frankston Hospital
Hastings Road
Frankston VIC 3199
Country 1920 0
Australia
Phone 1920 0
+61 3 97847445
Fax 1920 0
+61 3 97847441
Email 1920 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.