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

Phase 4

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)

• Registration Number: NCT01428570
• Lead Sponsor: Kyunghee University Medical Center

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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-31
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study First Submitted QC: 2011-09-02
• Last Update Submitted: 2011-09-02
• Study First Posted: 2011-09-05
• Last Update Posted: 2011-09-05
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentax-AWS	Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)	Patients in this group will be intubated using Pentax-AWS
laryngoscopy	Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)	Patients in this group will be intubated using Macintosh laryngoscope.

Primary Outcome Measures

Name	Time	Method
Intubation Difficulty Scale(IDS) score	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.

Secondary Outcome Measures

Name	Time	Method
Cormack and Lehane grade	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.

Trial Locations

Locations (1)

Kyung Hee university hospital; 🇰🇷 Seoul, Korea, Republic of