Pentax Airway Scope (AWS) Intubation

Study Overview
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Brief Summary
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This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.

Detailed Description
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100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an Ease of Use visual analog score (VAS) measure.

Official Title
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A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope

Conditions
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Obesity

Intervention / Treatment
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* Device: Macintosh laryngoscope
* Device: Pentax AWS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subject is at least 18 years old BMI between 30 and 50 scheduled for elective surgery requiring orotracheal intubation Exclusion Criteria: a known difficult airway loose teeth subject pregnancy rapid sequence induction required subject is unable to give consent anesthesiologist considered use of the Pentax AWS to be contraindicated 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macintosh laryngoscope<br>Intubation with a Macintosh laryngoscope | Device: Macintosh laryngoscope<br>* Intubation with Macintosh laryngoscope<br>|
| Active Comparator: Pentax AWS<br>Intubation with a Pentax AWS | Device: Pentax AWS<br>* Intubation with Pentax AWS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Intubation | time between sufficient muscle relaxant and placement of intubation tube | time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Intubation | Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation | From the start of intubation until 24 hours after surgery | 
| Successful Intubation on the First Attempt | The count number of successful intubation on the first attempt | From the start of intubation until 24 hours after surgery | 
| The Number of Patients With Different Number of Intubation Attempts | We summarized the number of patients with one, two or three intubation attempts. | From the start of intubation until 24 hours after surgery | 
| The Number of Patients With Bleeding |  | From the start of intubation until 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, obese