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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentax-AWS<br>Patients in this group will be intubated using Pentax-AWS | Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)<br>* Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.<br>|
| Active Comparator: laryngoscopy<br>Patients in this group will be intubated using Macintosh laryngoscope. | Device: Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)<br>* Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack and Lehane grade | 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.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, obstructive, intubation