Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of the Fastrach and the CTrach Laryngeal mask airway to achieve placement of a breathing tube in the windpipe of patients where this may be difficult.

Detailed Description
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Participant will be randomly assigned to receive one of 2 conventional airway devices - the Fastrach Laryngeal Mask Airway or the CTrach Laryngeal Mask Airway. This study will compare the time required for successful intubation between the two devices. Postoperative visit will be performed to assess the participant's clinical condition and to receive participant's feed back.

Official Title
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Comparison Between the Fastrach and CTrach Laryngeal Mask Airway for Intubation of Patients With a Mallampati Score 3 or 4

Conditions
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Intubation

Intervention / Treatment
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* Device: Fastrach Laryngeal Mask
* Device: CTrach Laryngeal Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an ASA score of 1-3. Scheduled for elective surgical procedure Age 18 and above Patients with Mallampati airway classification scores III and IV Exclusion Criteria: Current pregnancy Patients undergoing brain aneurysm clipping brain arteriovenous malformation surgery or vascular surgery procedures Patients with obstructive sleep apnea or with a history of difficult ventilation Mouth opening less than 3 cm. Patients with indication for awake fiberoptic intubation or with a history of difficult intubation Patients with cancer of the neck or the upper airway Emergent surgery, patients requiring rapid sequence induction Patients with severe gastroesophageal reflux Patients with severe cardiac, pulmonary, hepatic or renal co-morbidities. 10. Patients unable to consent their participation in the study.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Fastrach Laryngeal Mask Airway intubation | Device: Fastrach Laryngeal Mask<br>* Intubation of difficult airway using Fastrach Laryngeal Mask<br>|
| Active Comparator: Group 2<br>Intubation of difficult airway using CTrach Laryngeal Mask | Device: CTrach Laryngeal Mask<br>* CTrach Laryngeal Mask intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy |  | from start of intubation to successfully intubated | 
| To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy |  | 60 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal mask, Difficult intubation