Comparison of the LMA Protector and the I-gel

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Device: I-gel; Device: Laryngeal mask airway protector

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I-gel group; After the induction of anesthesia, I-gel is inserted into the oropharyngeal space.	Device: I-gel; After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.
Experimental: LMA protector group; After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space.	Device: Laryngeal mask airway protector; After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal airway leak pressure	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.	At 5 min after the insertion of i-gel or LMA protector

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of insertion attempt for the successful placement	The numbers of insertion attempt for successful placement are counted.	During the insertion of i-gel or LMA protector
Insertion time	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).	During the insertion of i-gel or LMA protector
Ease of insertion	Ease of insertion is defined as follows. Easy: requiring no additional maneuver, fair: requiring 1 additional maneuver, difficult: requiring more than 1 additional maneuver.	During the insertion of i-gel or LMA protector
Ease of gastric tube insertion	Ease of garstic tube insertion is assessed as follows; easy, difficult, impossible.	At 25 min after the insertion of i-gel or LMA protector
The accuracy of insertion location of the device in the oropharyngeal space	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.	At 15 min after the insertion of i-gel or LMA protector
Blood staining on the i-gel or LMA protector	After removal of the device, the presence of blood staining on the device is checked.	Immediately after removal of i-gel or LMA protector
The incidence and severity of postoperative sore throat	Postoperative sore throat is assessed using a numerical rating scale (0-100 point).	At 1 and 24 h after surgery

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Jin-Young Hwang, M.D., Ph.D., SMG-SNU Boramae Medical Center

Publications and helpful links

General Publications

• Chang JE, Kim H, Lee JM, Min SW, Won D, Jun K, Hwang JY. A prospective, randomized comparison of the LMA-protector and i-gel in paralyzed, anesthetized patients. BMC Anesthesiol. 2019 Jul 4;19(1):118. doi: 10.1186/s12871-019-0785-8.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): January 19, 2018
• Study Completion (Actual): January 20, 2018

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: I-gel; Laryngeal mask airway protector
• Other Study ID Numbers: 20170104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No