Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 3:44 PM
Study NCT ID:
NCT00667693
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pentax Airway Scope (AWS) Intubation
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: