Fibrescope vs Videolaryngoscope for Nasotracheal Intubation

ConditionNo Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospitals Coventry and Warwickshire NHS Trust

About this trial

Patients having surgery under general anaesthesia require insertion of a breathing tube to keep the airway open. The technique of inserting a breathing tube through the nose into the trachea (airway) is known as nasotracheal intubation. This is the ideal airway for surgical procedures performed inside the mouth, such as complex teeth extractions and operations on the jaw.

Traditionally, the breathing tube is initially inserted blindly into the nasal cavity. Then, a video laryngoscope (a camera device) or a direct laryngoscope is used to visualise and guide the passage of tube into the trachea. This approach can be associated with difficulty passing the tube and has a high incidence of nasal trauma and nosebleed.

Alternatively, a flexible fibrescope ( flexible camera device) with pre-loaded tracheal tube is passed through the nostril first under vision, gently advanced through the nasal passage and then to the trachea. Once it is correctly placed in the trachea, the breathing tube is railroaded over it. This procedure allows the clinician to visualise the nasal passage and to choose most patent nostril and hence is likely to reduce risk of nosebleed as compared blind passage of tube through the nose. A videolaryngoscope has a camera on the blade that projects the image onto a monitor screen. As this is a rigid device, it can only be inserted through the oral cavity and allows the advancement of tube into the trachea. Both these techniques are currently used in the clinical practice. However, there are no studies to inform anaesthetists whether there are any differences in the incidence of nosebleed.

The investigators therefore wish to do a randomised comparison between flexible fibrescope and videolaryngocope to assess if use of the former is associated with any reduced risk or severity of nosebleed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients who do not want to take part or do not give consent

Patients unable to give written consent.

Patient physical status of ASA 4 and 5,

Patients deemed to require awake intubation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nasotracheal Intubation with Fibrescope

    Device

    Intubation of trachea via nasal route with Fibrescope (11302BDX Flex. Intubation Video Endoscope 4 x 65 Karl Storz)

  • Nasotracheal Intubation with Video laryngoscope

    Procedure/Surgery

    Intubation of trachea via nasal route using a videolaryngoscope (301-000-000 McGRATH™ with Mac Blade)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Flexible FibrescopeActive comparator 1 intervention
Group B: VideolarygoscopeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Nasal trauma score

a score of 0 to 3 will be provided no bleeding, moderate bleeding, or severe bleeding

Time frame
5 minutes from nasotracheal intubation

Secondary outcomes

1

nasal intubation smoothness score

A score of 0 to 3 being given; smooth insertion (0), slight resistance, insertion with great resistance and not possible to insert requiring change of nostril

Time frame
During nasotracheal Intubation
2

Total intubation time

time in seconds from insertion of fiberscope or video laryngoscope till first capnography trace

Time frame
During nasotracheal intubation
3

Laryngoscopy time

time in seconds from insertion of laryngoscope in the mouth to visualize the vocal cords or from insertion of fiberscope in the nostril to visualise the vocal cords

Time frame
During nasotracheal intubation
4

incidence of post operative sore throat

Number of patients having soret throat in the post operative period

Time frame
Between 3 to 24 hours after intervention (nasotracheal intubation)

Other outcomes

Sponsors and contacts

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