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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01428570

Enrollment

Registered

2011-09-05

Start date

2011-08-31

Completion date

2011-10-31

Last updated

2011-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

sleep apnea, obstructive, intubation

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.

Interventions

DEVICEPentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)

Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026