The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

Not Applicable

Completed

• Conditions: Anesthesia Insertion Complication; Airway Morbidity
• Interventions: Device: Foley Airway Stylet Tool; Device: introducer-tool

• Registration Number: NCT02048657
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-03
• Study Start: 2008-03
• Primary Completion: 2009-03
• Study Completion: 2013-06
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Study First Posted: 2014-01-29
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley group	Foley Airway Stylet Tool	The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion
I-Tool group	introducer-tool	the ProSeal LMA was inserted with a standard introducer-tool

Primary Outcome Measures

Name	Time	Method
Number of participants with successful airway establishment	half an hour	successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.

Secondary Outcome Measures

Name	Time	Method
hoarseness	2 days	severity of hoarseness was recorded in recovery room and in the coming morning
postoperative sore throat	2 days	sore throat recorded in recovery room and in the coming morning

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan