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Pentax Airway Scope (AWS) Intubation

This study has been completed.
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00667693
First received: April 24, 2008
Last updated: September 23, 2009
Last verified: September 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Pentax AWS Intubation Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • The primary study outcome will be the time to intubation (TTI) as measured by a blinded observer. [ Time Frame: time between sufficient muscle relaxant and placement of intubation tube ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 100
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667693

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

No publications provided

Responsible Party: John Doyle, MD, Ph.D, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00667693     History of Changes
Other Study ID Numbers: 08-046
Study First Received: April 24, 2008
Last Updated: September 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
intubation
obese

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013