Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

Study Overview
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Brief Summary
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the video stylet (VS), it is considered one of the newer devices in this category. It is a portable device with liquid crystal-display module screen for visualization of vocal cords. It is considered an alternative to the flexible fiberoptic endoscope especially in the developing countries where the device cost is the main limiting factor. It has many benefits such as being light weight, easy to clean, durable, chargeable, less expensive and reusable. However newer video stylet devices have not been formally evaluated for tracheal intubation in case of laterally positioned patients.

Detailed Description
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Following approval from Ethics and Research Committee of Theodor Bilharz Research Institute, the study protocol will be explained to the patients after taking their consent. Upon arrival to the operating room, a 20 G cannula will be sited intravenously and infusion of Ringer's solution will be started. Intravenous midazolam in a dose of 0.05 mg/ Kg will be given. Then, a five-lead electrocardiogram (GE-Datex Ohmeda 5 lead ECG cable), a pulse oximeter (GE- Datex Ohmeda adult finger spO2 sensor) and a non-invasive blood pressure monitor (GE-Datex Ohmeda NIBP cuff, adult double tube with bag) will be attached to the patient.

Official Title
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Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope. A Randomised Comparative Study for Intubation in Lateral Position.

Conditions
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Intubating Video Stylet

Intervention / Treatment
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* Device: video stylet
* Device: fiberoptic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age 18- 60 years. Both sexes American Society of Anesthesiologists(ASA) physical status classes I and II. Non-obese patients ( BMI <35) Exclusion Criteria: Difficult intubation; mallampati 3 or 4, Dental abnormalities, Cervical spine pathology that limits neck mobility , obese patients ( BMI ≥ 35) . Cardiovascular disease, hypertensive patients, Pregnant and nursing women, High risk of pulmonary aspiration. Patients at risk of bleeding either impaired bleeding profile or receiving anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group- video stylet intubation (VS)<br>trachea will be intubated using laryngoscopic assisted video stylet device in lateral position | Device: video stylet<br>* trachea will be intubated using laryngoscopic assisted video stylet device in lateral position<br>|
| Active Comparator: Group- fiberoptic intubation (FO)<br>: intubation will be done using fiberoptic device by the same anesthesiologist in lateral position | Device: fiberoptic<br>* intubation will be done using fiberoptic device by the same anesthesiologist in lateral position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | (defined as the time when the device is introduced into the mouth till it is removed after the confirmation of correct placement of ETT by the appearance of an optimal waveform on the capnograph | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation success rate | Intubation success rate | up to 1 hour | 
| Number of intubation attempts | Number of intubation attempts | up to 1 hour | 
| Hemodynamic stability | assessed based on MAP and HR, which will be measured at the following time intervals: before induction of anesthesia at baseline (BA), after induction of anesthesia but before tracheal intubation (T1), and immediately after successful intubation (T2) | up to 1 hour |