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Completed

NCT Number: NCT04229862

Effect of Head Elevation on LMA Insertion

The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.

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Key information

Conditions

Laryngeal Masks Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are scheduled transurethral bladder tumor resection under general anesthesia
  • 20-79 years of age
  • American Society of Anesthesiologists physical status ≤3
  • Patients who are voluntarily agreed to this clinical study

Exclusion criteria

  • History of difficult airway
  • Expected difficult airway by physical examination
  • Unstable teeth or teeth loss
  • Obesity (body mass index ≥ 30)
  • Recent history of upper respiratory infection
  • Patients who are not fasted or who are at risk of aspiration

Treatment and study plan

Laryngeal mask airway insertion

Procedure

Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection

Primary outcomes

  1. First attempt success rate

    Time frame: Immediately after mask airway insertion

    The rate of success at the first attempt of laryngeal mask airway insertion

Secondary outcomes

  1. The percentage of glottic opening score

    Time frame: Immediately after mask airway insertion

    The percentage of glottic opening by fiberoptic view

  2. Laryngeal mask airway insertion-related patient satisfaction

    Time frame: At postoperative 6 hours

    A seven-point Likert scale

  3. Second attempt success rate

    Time frame: Immediately after mask airway insertion

    The rate of success at the second attempt of laryngeal mask airway insertion

  4. Third attempt success rate

    Time frame: Immediately after mask airway insertion

    The rate of success at the third attempt of laryngeal mask airway insertion

  5. Oropharyngeal leak pressure

    Time frame: Immediately after mask airway insertion

    Oropharyngeal leak pressure is measured as follows: After setting the expiratory valve to 30 cmH2O at a fixed gas flow rate of 3 L/min, the maximum inflation pressure is measured when a noise of gas leakage is heard in the oropharynx via a stethoscope.

  6. Reposition rate

    Time frame: After mask airway insertion (up to end of surgery)

    The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks

  7. Complications associated with laryngeal mask airway insertion

    Time frame: Up to postoperative 3 days

    Complications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Effect of Head Elevation on LMA Supreme Insertion in Patients Undergoing Transurethral Resection of Bladder Tumor: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
May 29, 2020

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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