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Pentax Airway Scope (AWS) Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667693
First Posted: April 28, 2008
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose
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.

Condition Intervention
Obesity Device: Macintosh intubation Device: Pentax AWS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Pentax AWS Intubation Study

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Secondary Outcomes Will Include Ease of Intubation (as Recorded by the Operator Immediately After Intubation on a 100 mm Visual Analog Scale [VAS]), the Number of Failures, the Number of Attempts Made, and the Amount of Bleeding That Occurred. [ Time Frame: intraoperative, first post op morning ]

Enrollment: 101
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intubation with a Macintosh laryngoscope
Device: Macintosh intubation
Macintosh intubation
Active Comparator: 2
intubation with a the Pentax AWS
Device: Pentax AWS
Intubation with Pentax AWS

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ETT is needed for the case.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667693


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Principal Investigator: John Doyle, MD, PhD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00667693     History of Changes
Other Study ID Numbers: 08-046
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: July 18, 2016
Results First Posted: October 31, 2016
Last Update Posted: December 1, 2017
Last Verified: September 2016

Keywords provided by The Cleveland Clinic:
intubation
obese