Skip to content

A comparison of two intubation aids in the management of anticipated difficult tracheal intubation

Flexible Tip Bougie versus C-MAC Stylet in the management of anticipated difficult intubation in patients undergoing elective surgery. A pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001034123
Enrollment
40
Registered
2019-07-19
Start date
2019-07-29
Completion date
2019-09-02
Last updated
2020-01-06

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

Conditions

None listed

Brief summary

In patients in whom intubation of the airway is predicted to be difficult, a C-MAC D-blade videolaryngoscope™ (Karl Storz Endoscopy, Tuttlingen, Germany) is commonly used to improve visualisation of the Glottis. Due to the high angulation of the D-Blade it is not uncommon to encounter a "can see, cannot intubate" situation, This study will compare the intubation times of two airway adjuncts used with the CMAC D-blade - the Construct Medical Flexible Tip Bougie, and the GlideRite rigid stylet, We hypothesise that the flexible tip bougie will offer improved speed of intubation owing to its ability to adjust the direction of the bougie tip during the intubation.

Interventions

The Construct Medical Flexible Tip Bougie (the intervention) will be used to assist with intubation in patients requiring videolaryngoscopy with a CMAC D-Blade. The Construct Medical Flexible Tip Bougie is an alternative tool, also designed to overcome the "can see, can’t intubate" scenario. This device incorporates a slider, controlled with the thumb and the forefinger, to guide the tip anteriorly, guiding it through the glottis. Furthermore, the ability to also flex the tip posteriorly once

The Construct Medical Flexible Tip Bougie (the intervention) will be used to assist with intubation in patients requiring videolaryngoscopy with a CMAC D-Blade. The Construct Medical Flexible Tip Bougie is an alternative tool, also designed to overcome the "can see, can’t intubate" scenario. This device incorporates a slider, controlled with the thumb and the forefinger, to guide the tip anteriorly, guiding it through the glottis. Furthermore, the ability to also flex the tip posteriorly once past the vocal cords, may avoid the problem of the ETT hitting the anterior tracheal wall and impeding passage of the tube. , Once manipulated into position, the ETT is passed over the bougie, into the trachea. The intubation will be performed by an anaesthetist with at least 3 years anaesthesia experience. A single intubation will be performed for each recruited patient, following the induction anaesthesia. Details of whether or not the patient was successfully intubated with the allocated device will be collected on the case report form, including which, if any, additional airway devices were required.

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

• Adults (>18years) able to provide informed consent • Booked for elective, non-cardiac surgery • Presence of at least one predictor of increased difficulty of intubation (Any of: prior history of difficult intubation, thyromental distance (<6cm), mouth opening (<2cm), decreased neck extension, Mallampati grade 3+, decreased jaw protrusion)

Exclusion criteria

• Age under 18 years • Unable to give informed consent to participate • Would not routinely require routine endotracheal intubation for the surgical procedure • Known disease of airway (tumour, infection, tracheal stenosis, tracheomalacia) • Recent airway surgery (within 6 weeks) • Difficult airway necessitating awake intubation • Allergy to fentanyl, propofol or rocuronium

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026