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Pentax Airway Scope (AWS) Intubation

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ClinicalTrials.gov Identifier: NCT00667693
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : October 31, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Obesity Device: Macintosh laryngoscope Device: Pentax AWS Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Active Comparator: Macintosh laryngoscope
Intubation with a Macintosh laryngoscope
Device: Macintosh laryngoscope
Intubation with Macintosh laryngoscope

Active Comparator: Pentax AWS
Intubation with a Pentax AWS
Device: Pentax AWS
Intubation with Pentax AWS




Primary Outcome Measures :
  1. 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 :
  1. Ease of Intubation [ Time Frame: From the start of intubation until 24 hours after surgery ]
    Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation

  2. Successful Intubation on the First Attempt [ Time Frame: From the start of intubation until 24 hours after surgery ]
    The count number of successful intubation on the first attempt

  3. The Number of Patients With Different Number of Intubation Attempts [ Time Frame: From the start of intubation until 24 hours after surgery ]
    We summarized the number of patients with one, two or three intubation attempts.

  4. The Number of Patients With Bleeding [ Time Frame: From the start of intubation until 24 hours after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 endotracheal tube (ETT) is needed for the case.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667693


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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00667693     History of Changes
Other Study ID Numbers: 08-046
First Posted: April 28, 2008    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by The Cleveland Clinic:
intubation
obese