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

This study is currently recruiting participants.
Verified September 2011 by Kyunghee University Medical Center
Sponsor:
Information provided by (Responsible Party):
Mi Kyeong Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01428570
First received: August 31, 2011
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Apnea, Obstructive
 Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Comparison of the Pentax AWS® With the Macintosh Laryngoscope for Tracheal Intubation in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Comparative Study

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Intubation Difficulty Scale(IDS) score [ Time Frame: After the end of intubation (within 10 minute after the end of intubation.) ] [ Designated as safety issue: No ]
    IDS score will be recorded within 10 minute after the end of intubation.


Secondary Outcome Measures:
  • Cormack and Lehane grade [ Time Frame: After the end of intubation (within 10 minute after the end of intubation.) ] [ Designated as safety issue: No ]
    Cormack and Lehane grade will be recorded within 10 minute after the end of intubation.


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
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.
Other Name: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428570

Locations
Korea, Republic of
Kyung Hee university hospital Recruiting
Seoul, Korea, Republic of, 130-701
Contact: Mi Kyeong Kim, Professor     82-2-958-8604 ext 82-2-958-8114     mkanes@gmail.com    
Principal Investigator: Mi Kyeong Kim, Professor            
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Mi Kyeong Kim, Professor Kyung-Hee University Hospital
  More Information

No publications provided

Responsible Party: Mi Kyeong Kim, Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01428570     History of Changes
Other Study ID Numbers: PEN
Study First Received: August 31, 2011
Last Updated: September 2, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
sleep apnea, obstructive
intubation

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013