Pentax Airway Scope (AWS) Intubation

NCT ID: NCT00667693

Last Updated: 2018-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-03-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Macintosh laryngoscope

Intubation with a Macintosh laryngoscope

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

Intubation with Macintosh laryngoscope

Pentax AWS

Intubation with a Pentax AWS

Group Type ACTIVE_COMPARATOR

Pentax AWS

Intervention Type DEVICE

Intubation with Pentax AWS

Interventions

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Macintosh laryngoscope

Intubation with Macintosh laryngoscope

Intervention Type DEVICE

Pentax AWS

Intubation with Pentax AWS

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel I Sessler, MD

Role: STUDY_CHAIR

The Cleveland Clinic

John Doyle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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08-046

Identifier Type: -

Identifier Source: org_study_id

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