Pentax Airway Scope (AWS) Intubation

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. Identifier: NCT00667693
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : October 31, 2016
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Device: Macintosh intubation Device: Pentax AWS Not Applicable

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  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Pentax AWS Intubation Study
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00667693

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

Responsible Party: The Cleveland Clinic Identifier: NCT00667693     History of Changes
Other Study ID Numbers: 08-046
First Posted: April 28, 2008    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: March 8, 2018
Last Verified: January 2018

Keywords provided by The Cleveland Clinic: