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

NCT ID: NCT01428570

Last Updated: 2011-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-10-31

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Pentax-AWS

Patients in this group will be intubated using Pentax-AWS

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

laryngoscopy

Patients in this group will be intubated using Macintosh laryngoscope.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyunghee University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mi Kyeong Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi Kyeong Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital

Locations

Kyung Hee university hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Mi Kyeong Kim, Professor

Role: primary

mkanes@gmail.com

82-2-958-8604 ext. 82-2-958-8114

Other Identifiers

PEN

Identifier Type: -

Identifier Source: org_study_id