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Pentax Airway Scope (AWS) Intubation

This study has been completed.
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: April 24, 2008
Last updated: September 13, 2016
Last verified: September 2016
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)
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: The Cleveland Clinic Identifier: NCT00667693     History of Changes
Other Study ID Numbers: 08-046
Study First Received: April 24, 2008
Results First Received: July 18, 2016
Last Updated: September 13, 2016

Keywords provided by The Cleveland Clinic:
obese processed this record on September 21, 2017