C-MAC Video-stylet for Double- Lumen Tracheal Intubation

Study Overview
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Brief Summary
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C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.

Detailed Description
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It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.

Official Title
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C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study

Conditions
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Single Lung Ventilation, Thoracic Anesthesia

Intervention / Treatment
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* Device: C-MAC video-stylet
* Device: Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-60 years, of both sex of American Society of Anesthesiologists (ASA) physical Status II and III undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -< 35 kg/m2, with Mallampati score of 1 or 2 Exclusion Criteria: Mallampati score > =3; inter-incisor distance < 3 cm; thyromental distance < 6 cm; neck extension < 80°from neck flexion; cervical spine instability; history of difficult endotracheal intubation r difficult mask ventilation; - severe pulmonary ventilation dysfunction risk of pulmonary aspiration.

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-MAC-VS group<br>C-MAC-VS will be used to facilitate intubation | Device: C-MAC video-stylet<br>* Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.<br>|
| Placebo Comparator: control group<br>direct laryngoscopy using Macintosh laryngoscope will be done for DLT insertion. | Device: Macintosh laryngoscope<br>* Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time taken for intubation (TTI) by C-MAC-VS | timing for intubation | 5 minutes |