Comparison of the Pentax AWS® With the Macintosh Laryngoscopic Intubation in Obstructive Sleep Apnea Syndrome Patients

September 2, 2011 updated by: Mi Kyeong Kim, Kyunghee University Medical Center

Comparison of the Pentax AWS® With the Macintosh Laryngoscope for Tracheal Intubation in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Comparative Study

The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Pentax-AWS improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in Obstructive Sleep Apnea Syndrome (OSAS) patients and to compare its performance with the Macintosh laryngoscope.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The occurrence of difficult intubation in OSAS patients is higher than in age and sex matched control patients. The Pentax-AWS_ system (AWS; Pentax Corporation, Tokyo, Japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. Several studies reported that Pentax-AWS improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. The purpose of this clinical trial was to evaluate the relative efficacy of the AWS laryngoscopes when used by experienced anesthetists in OSAS patients and to compare its performance with the Macintosh laryngoscope. The investigators hypothesized that, in comparison with the Macintosh, AWS would reduce intubation difficulty, as measured by the intubation difficulty scale (IDS) score.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 130-701
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
          • Mi Kyeong Kim, Professor
          • Phone Number: 82-2-958-8114 82-2-958-8604
          • Email: mkanes@gmail.com
        • Principal Investigator:
          • Mi Kyeong Kim, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status 1-3 patients,
  • aged 20years or older,
  • undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.

Exclusion Criteria:

  • unstable teeth or mouth opening of < 18mm
  • Patients with any pathology of the neck,
  • upper respiratory tract or upper alimentary tracts,
  • risk of pulmonary aspiration of gastric contents,
  • a history of relevant drug allergy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pentax-AWS
Patients in this group will be intubated using Pentax-AWS
Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.
ACTIVE_COMPARATOR: laryngoscopy
Patients in this group will be intubated using Macintosh laryngoscope.
Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Difficulty Scale(IDS) score
Time Frame: After the end of intubation (within 10 minute after the end of intubation.)
IDS score will be recorded within 10 minute after the end of intubation.
After the end of intubation (within 10 minute after the end of intubation.)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cormack and Lehane grade
Time Frame: After the end of intubation (within 10 minute after the end of intubation.)
Cormack and Lehane grade will be recorded within 10 minute after the end of intubation.
After the end of intubation (within 10 minute after the end of intubation.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Mi Kyeong Kim, Professor, Kyung Hee University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (ESTIMATE)

September 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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