Comparison of the LMA Protector and the I-gel

NCT03078517 | Completed DMC

• 1 other identifier: 20170104
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

I-gel; Laryngeal mask airway protector

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of insertion attempt for the successful placement

  During the insertion of i-gel or LMA protector

• Insertion time

  During the insertion of i-gel or LMA protector

• Ease of insertion

  During the insertion of i-gel or LMA protector

• Ease of gastric tube insertion

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

• The accuracy of insertion location of the device in the oropharyngeal space

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

Study Arms (2)

I-gel group

ACTIVE COMPARATOR

After the induction of anesthesia, I-gel is inserted into the oropharyngeal space.

Device: I-gel

LMA protector group

EXPERIMENTAL

After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space.

Device: Laryngeal mask airway protector

Interventions

I-gel DEVICE

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

I-gel group

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.

LMA protector group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Requirement for mechanical ventilation under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• SMG-SNU Boramae Medical Center: lead

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31272379 DERIVED

Study Officials

• Jin-Young Hwang, M.D., Ph.D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: March 13, 2017
• Study Start: May 1, 2017
• Primary Completion: January 19, 2018
• Study Completion: January 20, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)