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OPTICAL STYLET INTUBATION: A COMPARISON OF THE BONFILS STYLET (RETROMOLAR APPROACH) WITH LEVITAN STYLET (MIDLINE APPROACH) FOR ROUTINE INTUBATION.

Optical stylet intubation: a comparison of intubation success rate of the Bonfils stylet (retromolar approach) with Levitan stylet (midline approach) for routine intubation.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000309482
Enrollment
320
Registered
2007-06-13
Start date
2007-09-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Dr Ashley Webb
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Consented adult elective surgical patients with no anticipated airway difficulties (Mallampati scores 1-3)

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026