The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

NCT ID: NCT02048657

Last Updated: 2014-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Anesthesia Insertion Complication Airway Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Foley group

The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion

Group Type EXPERIMENTAL

Foley Airway Stylet Tool

Intervention Type DEVICE

I-Tool group

the ProSeal LMA was inserted with a standard introducer-tool

Group Type EXPERIMENTAL

introducer-tool

Intervention Type DEVICE

Interventions

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Foley Airway Stylet Tool

Intervention Type DEVICE

introducer-tool

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuang I Cheng, MD, PhD.

Role: STUDY_DIRECTOR

Department of anesthesiology, Kaohsiung Medical University, Taiwan

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

Site Status

Countries

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Taiwan

References

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Chen MK, Hsu HT, Lu IC, Shih CK, Shen YC, Tseng KY, Cheng KI. Techniques for the insertion of the ProSeal laryngeal mask airway: comparison of the Foley airway stylet tool with the introducer tool in a prospective, randomized study. BMC Anesthesiol. 2014 Nov 18;14:105. doi: 10.1186/1471-2253-14-105. eCollection 2014.

Reference Type DERIVED
PMID: 25435806 (View on PubMed)

Other Identifiers

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KMHK-IRB-96023

Identifier Type: -

Identifier Source: org_study_id

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