Pentax Airway Scope (AWS) Intubation

July 23, 2018 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macintosh laryngoscope
Intubation with a Macintosh laryngoscope
Device: Macintosh laryngoscope
Intubation with Macintosh laryngoscope
Active Comparator: Pentax AWS
Intubation with a Pentax AWS
Device: Pentax AWS
Intubation with Pentax AWS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intubation
Time Frame: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
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
Time Frame: From the start of intubation until 24 hours after surgery
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
Time Frame: From the start of intubation until 24 hours after surgery
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
Time Frame: From the start of intubation until 24 hours after surgery
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
Time Frame: From the start of intubation until 24 hours after surgery
From the start of intubation until 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: John Doyle, MD, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 28, 2008

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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