Comparison of the LMA Protector and the I-gel

Mechanical Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078517
• Other study ID #: 20170104
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: February 1, 2018
• Start date: May 1, 2017
• Est. completion date: January 20, 2018

Study information

• Verified date: February 2018
• Source: SMG-SNU Boramae Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: January 20, 2018
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Device:
• I-gel
After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.
• Laryngeal mask airway protector
After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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