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A Study Comparing the Laryngeal Mask Airway Supreme With the Laryngeal Mask Airway Protector In the Ambulatory Surgery Unit

NCT03462550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-04

No results posted yet for this study

Summary

The Laryngeal Mask Airway is a supraglottic airway device that has been used in anesthesia for decades. Now the third generation (LMA Supreme) is commonly used. Recently the LMA Protector is manufactured.

The primary hypothesis of this study is: the oropharyngeal leak pressure of the LMA Protector is 5 cmH2O higher than the oropharyngeal leak pressure of the LMA Supreme. Secondary outcome measures are: ease of insertion, fibreoptic position, ease of gastric tube placement.

Differences between LMA Supreme and LMA Protector are: the LMA protector has a dual gastric drainage channel, LMA supreme one. For LMA protector, airway tube and cuff are 100% silicone, in LMA supreme the cuff is polivinylchloride. Silicone cuffs have shown to reduce risk of sore throat and achieve higher seal pressures. There are no aperture bars in the LMA protector (2 in LMA supreme). The tube of LMA protector is more flexible. An integrated cuff pressure indicator for single use airway management devices that enables continuous cuff pressure monitoring only in the LMA protector.

Conditions

  • Airway Complication of Anesthesia

Interventions

DEVICE

Laryngeal mask

LMA insertion

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2018-03-21
Completion
2018-03-21

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462550 on ClinicalTrials.gov