Comparison of the LMA Protector and the I-gel

Not Applicable

Completed

• Conditions: Mechanical Ventilation
• Interventions: Device: Laryngeal mask airway protector; Device: I-gel

• Registration Number: NCT03078517
• Lead Sponsor: SMG-SNU Boramae Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Study Start: 2017-05-01
• Primary Completion: 2018-01-19
• Study Completion: 2018-01-20
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA protector group	Laryngeal mask airway protector	After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space.
I-gel group	I-gel	After the induction of anesthesia, I-gel is inserted into the oropharyngeal space.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal airway leak pressure	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 Outcome Measures

Name	Time	Method
Ease of insertion	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.
The incidence and severity of postoperative sore throat	At 1 and 24 h after surgery	Postoperative sore throat is assessed using a numerical rating scale (0-100 point).
The accuracy of insertion location of the device in the oropharyngeal space	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.
Insertion time	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).
Blood staining on the i-gel or LMA protector	Immediately after removal of i-gel or LMA protector	After removal of the device, the presence of blood staining on the device is checked.
Number of insertion attempt for the successful placement	During the insertion of i-gel or LMA protector	The numbers of insertion attempt for successful placement are counted.
Ease of gastric tube insertion	At 25 min after the insertion of i-gel or LMA protector	Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible.

Trial Locations

Locations (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of