GlideScope Video Laryngoscope Versus Fiberoptic Intubation

Study Overview
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Brief Summary
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Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.

Official Title
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GlideScope Video Laryngoscope vs Fiberoptic Intubation

Conditions
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Oral Intubation

Intervention / Treatment
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* Device: Intubation with Fiberoptic laryngoscope
* Device: GlideScope® Video Laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years old scheduled for elective surgery requiring orotracheal intubation. Exclusion Criteria: known, difficult airway loose teeth pregnant require a rapid sequence induction, Body Mass Index under 30 unable to give consent if special endotracheal tube (ETT) is needed for the case.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fiberoptic Intubation<br>Subjects will be intubated with the Fiberoptic laryngoscope. | Device: Intubation with Fiberoptic laryngoscope<br>* Subjects will be intubated with the Fiberoptic laryngoscope.<br>* Other names: laryngoscope;|
| Active Comparator: GlideScope® Video Laryngoscope<br>Subjects will be intubated with the GlideScope® Video Laryngoscope. | Device: GlideScope® Video Laryngoscope<br>* Patients will be intubated with the GlideScope® Video Laryngoscope.<br>* Other names: Video Laryngoscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation (TTI) as Measured in Seconds | Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg). | from start of intubation to successfully intubated up to 100 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Difficulty Score | Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult); | from start of intubation to successfully intubated | 
| Successful Intubation on 1st Attempt |  | from start of first intubation to end of first intubation attempt | 
| Occurrence of Hypoxaemia | Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements. | at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after | 
| Trace Bleeding | Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube | Right after intubation | 
| Sore Throat Grade |  | On the first postoperative day | 
| Number of Intubation Attempts |  | from start of intubation to successfully intubated | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elective general surgery, orotracheal intubation, Patients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.