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Completed

NCT Number: NCT03078517

Comparison of the LMA Protector and the I-gel

Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.

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Key information

Conditions

Mechanical Ventilation

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Requirement for mechanical ventilation under general anesthesia

Exclusion criteria

  • Surgical position other than supine position
  • Tumors or anatomical abnormalities in the upper airway
  • Known or predicted difficult airway
  • Body mass index > 30 kg/m2
  • Required postoperative mechanical ventilation
  • Head and neck surgery
  • Aspiration tendency

Treatment and study plan

I-gel

Device

After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.

Laryngeal mask airway protector

Device

After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.

Primary outcomes

  1. Oropharyngeal airway leak pressure

    Time frame: At 5 min after the insertion of i-gel or LMA protector

    Oropharyngeal airway leak pressure is measured by closing the expiratory valve of the circle system at a fresh gas flow of 3 L/min and observing the airway pressure at equilibrium.

Secondary outcomes

  1. Number of insertion attempt for the successful placement

    Time frame: During the insertion of i-gel or LMA protector

    The numbers of insertion attempt for successful placement are counted.

  2. Insertion time

    Time frame: During the insertion of i-gel or LMA protector

    Insertion time is defined as the time from picking up the device to confirming successful placement (the appearance of the ETCO2 on the monitor screen).

  3. Ease of insertion

    Time frame: During the insertion of i-gel or LMA protector

    Ease of insertion is defined as follows. Easy: requiring no additional maneuver, fair: requiring 1 additional maneuver, difficult: requiring more than 1 additional maneuver.

  4. Ease of gastric tube insertion

    Time frame: At 25 min after the insertion of i-gel or LMA protector

    Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible.

  5. The accuracy of insertion location of the device in the oropharyngeal space

    Time frame: At 15 min after the insertion of i-gel or LMA protector

    After insertion of the device, the insertion location is assessed using a fiberoptic bronchoscope; 4, only the vocal cords seen; 3, vocal cords and posterior part of the epiglottis seen; 2, vocal cords and anterior part of the epiglottis seen; 1, vocal cords not seen, but adequate ventilation.

  6. Blood staining on the i-gel or LMA protector

    Time frame: Immediately after removal of i-gel or LMA protector

    After removal of the device, the presence of blood staining on the device is checked.

  7. The incidence and severity of postoperative sore throat

    Time frame: At 1 and 24 h after surgery

    Postoperative sore throat is assessed using a numerical rating scale (0-100 point).

Sponsors and collaborators

Lead sponsor

SMG-SNU Boramae Medical Center

Other

Registry information

Official study title

Comparison of the LMA Protector and the I-gel in Anesthetized Patients.

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2017
Registry last updated
Feb 5, 2018

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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