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The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02048657
Enrollment
140
Registered
2014-01-29
Start date
2008-03-31
Completion date
2013-06-30
Last updated
2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity, Anesthesia Insertion Complication

Keywords

LMA, Foley Airway Stylet Tool (FAST), introducer-tool (I-Tool)

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).

Interventions

DEVICEFoley Airway Stylet Tool
DEVICEintroducer-tool

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with successful airway establishmenthalf an hoursuccessful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.

Secondary

MeasureTime frameDescription
postoperative sore throat2 dayssore throat recorded in recovery room and in the coming morning
hoarseness2 daysseverity of hoarseness was recorded in recovery room and in the coming morning

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026