Comparison of the Pentax AWS® With the Macintosh Laryngoscopic Intubation in Obstructive Sleep Apnea Syndrome Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 5, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedSeptember 5, 2011
September 1, 2011
1 month
August 31, 2011
September 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intubation Difficulty Scale(IDS) score
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 Outcomes (1)
Cormack and Lehane grade
After the end of intubation (within 10 minute after the end of intubation.)
Study Arms (2)
Pentax-AWS
EXPERIMENTALPatients in this group will be intubated using Pentax-AWS
laryngoscopy
ACTIVE COMPARATORPatients in this group will be intubated using Macintosh laryngoscope.
Interventions
Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.
Eligibility Criteria
You may qualify if:
- ASA physical status 1-3 patients,
- aged 20years or older,
- undergoing uvulopalatopharyngoplasty(UPPP) surgery under general anesthesia for a polysomnography-confirmed diagnosis of OSAS.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee university hospital
Seoul, 130-701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mi Kyeong Kim, Professor
Kyung Hee University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 31, 2011
First Posted
September 5, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
September 5, 2011
Record last verified: 2011-09