Not Yet RecruitingPhase 4ACTRN12607000309482

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.


Sponsor

Dr Ashley Webb

Enrollment

320 participants

Start Date

Sep 1, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two optical stylet devices (Bonfils and Levitan) used for inserting a breathing tube during general anaesthesia. It is for adults aged 18 and older undergoing planned surgery with no expected airway difficulties.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 intuba

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.


Locations(1)

Australia

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ACTRN12607000309482