Pentax Airway Scope (AWS) Intubation
A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
October 31, 2016
CompletedJuly 24, 2018
July 1, 2018
1.1 years
April 24, 2008
July 18, 2016
July 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Intubation
time between sufficient muscle relaxant and placement of intubation tube
time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
Secondary Outcomes (4)
Ease of Intubation
From the start of intubation until 24 hours after surgery
Successful Intubation on the First Attempt
From the start of intubation until 24 hours after surgery
The Number of Patients With Different Number of Intubation Attempts
From the start of intubation until 24 hours after surgery
The Number of Patients With Bleeding
From the start of intubation until 24 hours after surgery
Study Arms (2)
Macintosh laryngoscope
ACTIVE COMPARATORIntubation with a Macintosh laryngoscope
Pentax AWS
ACTIVE COMPARATORIntubation with a Pentax AWS
Interventions
Eligibility Criteria
You may qualify if:
- subject is at least 18 years old
- BMI between 30 and 50
- scheduled for elective surgery requiring orotracheal intubation
You may not qualify if:
- 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 endotracheal tube (ETT) is needed for the case.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
It focused on obese patients; did not include patients with a history of difficult intubation; protocol did not include use of adjunctive devices; was impossible to blind the operator to the device being used; only the Mallampati score was recorded
Results Point of Contact
- Title
- Daniel I Sessler, MD
- Organization
- Cleveland Clinic Foundation
Study Officials
- STUDY CHAIR
Daniel I Sessler, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
John Doyle, MD, PhD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
July 24, 2018
Results First Posted
October 31, 2016
Record last verified: 2018-07