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OpenTrials
Completed

NCT Number: NCT02048657

The Effectiveness of Foley Airway Stylet Tool on Proseal LMA Insertion

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).

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Key information

Conditions

Anesthesia Insertion Complication Airway Morbidity Behavior Fasting Feeding Behavior

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with American Society of Anesthesiologists physical status I-II
  • aged 20-65 years
  • requiring LMA Intubation under general anesthesia
  • unlimited mouth open
  • unlimited neck motion

Exclusion criteria

  • mouth open < 3 cm
  • limited neck motion
  • BMI≧35 kg/m2

Treatment and study plan

Foley Airway Stylet Tool

Device

introducer-tool

Device

Primary outcomes

  1. Number of participants with successful airway establishment

    Time frame: 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 outcomes

  1. postoperative sore throat

    Time frame: 2 days

    sore throat recorded in recovery room and in the coming morning

  2. hoarseness

    Time frame: 2 days

    severity of hoarseness was recorded in recovery room and in the coming morning

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2013
First posted
Jan 29, 2014
Registry last updated
Jan 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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