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The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

K

Kaohsiung Medical University

Status

Completed

Conditions

Anesthesia Insertion Complication
Airway Morbidity

Treatments

Device: Foley Airway Stylet Tool
Device: introducer-tool

Study type

Interventional

Funder types

Other

Identifiers

NCT02048657
KMHK-IRB-96023

Details and patient eligibility

About

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).

Enrollment

140 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

140 participants in 2 patient groups

Foley group
Experimental group
Description:
The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion
Treatment:
Device: Foley Airway Stylet Tool
I-Tool group
Experimental group
Description:
the ProSeal LMA was inserted with a standard introducer-tool
Treatment:
Device: introducer-tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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