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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01428570
• Other study ID #: PEN
• Status: Recruiting
• Phase: Phase 4
• First received: August 31, 2011
• Last updated: September 2, 2011
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: September 2011
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)
Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	No
Secondary	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.)	No