Flexible Fibrescope Versus Video Laryngoscope for Nasotracheal Intubation - A Randomised Comparison
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
Study Overview
Brief Summary
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 a has high incidence of nasal trauma and nosebleed. 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 to visualise the nasal passage and to choose most patent nostril and hence 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 the anaesthetists whether there are any differences in the incidence of nosebleed.
We wish to do a randomised comparison between flexible fibrescope and videolaryngocope in terms reducing the risk and severity of nosebleed.
Patients aged 18 and above, presenting for elective surgical procedures and requiring general anaesthesia and nasal intubation will be invited to take part in the study. We are aiming to recruit 200 participants (see sample size section) to see any significant differences in the incidence of nosebleed.
Patients who are eligible and consent to take part in the study will be randomly allocated either to flexible fibrescope group or to videolaryngoscope. At the time of nasotracheal intubation, smoothness of nasal intubation, severity of bleeding from the nose and time taken to complete the tracheal intubation will be noted. Five minutes after intubation, the surgeon performing surgery (blinded to the technique of intubation) will be examining the oral cavity for any bleeding. This will be graded using a standardised nasal bleeding score. All patients will be visited in the post operative period to check any ongoing nosebleed and nasal discomfort. Patient details that will be collected includes gender, age, weight, height, body mass index and airway assessment parameters. No other personal data is required.
This study aims to see whether the use of flexible fibrescope reduces nasal bleeding and improves patient safety. If there is no difference, it may provide reassurance in the continued use of video laryngoscopy for nasal intubation.
Detailed Description
STUDY PROTOCOL
FLEXIBLE FIBRESCOPE VERSUS VIDEOLARYNGOSCOPE FOR NASOTRACHEAL INTUBATION- A RANDOMISED COMPARISON
- INTRODUCTION The technique of inserting a tracheal tube through the nasal passage into the trachea (airway) is known as nasotracheal intubation. This is the preferred airway for surgical procedures performed in and around oral cavity including dental procedures. Traditionally, the tracheal tube is initially inserted blindly into the nasal cavity. A laryngoscope is then used to visualise and help guide the passage of the tube into the trachea. This approach can be associated with difficulty passing the tube and a high incidence of nasal trauma [1, 2], as the nasal passages can be narrow and demonstrate inter-individual anatomic variability. Therefore, various approaches have been described in the literature to reduce nasal trauma including warming the tube [3], applying water-based lubricants and preparing the nasopharynx with progressive dilation and/or a topical vasoconstrictors [4]. There have been randomised studies using curve-tipped suction catheters [2], and bougies [1,5] showing reduced incidence of nasal trauma as compared to blind passage of the tube through the nose. However, as these devices are blindly inserted through the nasal passage, the device itself can cause some degree of trauma. Using a fiberscope allows for an assessment of the patency of the nasal passages and visualisation of the path the tube will take through the nasopharynx. We therefore hypothesise that using a flexible fiberscope for nasal intubation will reduce nasal trauma.
A flexible fiberscope (A in Figure below) is a device that employs flexible fibreoptic bundles to allow the transmission of an image via internal reflection of light. The image is then transmitted to an external screen. These devices were first used in the 1950's and allow successful intubation of the trachea for both anticipated and unanticipated difficult airways [6].
A video laryngoscope has a camera on the blade that projects the image onto a monitor screen (B in Figure below). This means that the person intubating can see around the corner and get a better view of the vocal cords. Unlike a flexible fiberscope, video laryngoscopes can only be inserted through the mouth and therefore can't visualise the nasal passages. Therefore, passage of the tube through the nasal passage is blind when video laryngoscopy is used for nasal intubation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 and above, presenting for elective surgical procedures and requiring general anaesthesia and nasal intubation will be invited to take part in the study.
Exclusion Criteria
- •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.
