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NCT02048657 Clinical Trial

The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

Airway Morbidity Clinical Trial

Official title:
The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02048657
Other study ID # KMHK-IRB-96023
Secondary ID
Status Completed
Phase N/A
First received October 23, 2013
Last updated January 27, 2014
Start date March 2008
Est. completion date June 2013

Study information
Verified date March 2008
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date June 2013
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-II

2. aged 20-65 years

3. requiring LMA Intubation under general anesthesia

4. unlimited mouth open

5. unlimited neck motion

Exclusion Criteria:

1. mouth open < 3 cm

2. limited neck motion

3. BMI?35 kg/m2

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Foley Airway Stylet Tool

• introducer-tool

Locations
Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with successful airway establishment successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions. half an hour Yes
Secondary postoperative sore throat sore throat recorded in recovery room and in the coming morning 2 days Yes
Secondary hoarseness severity of hoarseness was recorded in recovery room and in the coming morning 2 days Yes
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