Pentax AWS Intubation - Full Text View

Sponsored by:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00667693

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

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Pentax AWS Intubation Study

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: intraoperative ] [ 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 ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intubation with a Macintosh laryngoscope	Device: Macintosh intubation Macintosh intubation
2: Active Comparator 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

Contacts

Contact: Nancy Graham, BA,CCRP

216-445-7530

grahamn@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nancy Graham, BA,CCRP 216-445-7530 grahamn@ccf.org

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Study Chair:	Daniel I Sessler, MD	Cleveland Clinic
Principal Investigator:	John Doyle, MD, PhD	Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic ( John Doyle, MD, Ph.D )
Study ID Numbers:	08-046
Study First Received:	April 24, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00667693
Health Authority:	United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:

intubation
obese

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009