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

NCT03462550 | Completed DMC

• 1 other identifier: EC/2017/0117
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Airway Leak Pressure

  perioperative

Study Arms (2)

LMA Supreme

ACTIVE COMPARATOR

Device: Laryngeal mask

LMA Protector

EXPERIMENTAL

Device: Laryngeal mask

Interventions

Laryngeal mask DEVICE

LMA insertion

LMA Protector; LMA Supreme

Eligibility Criteria

• Age: 19 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are planned for elective minor surgery in the ambulatory surgery unit, who are ASA I or II or III, aged 19-71 years, whose operation is routinely done with a Laryngeal Mask Airway in the supine position.

You may not qualify if:

• Patients are excluded if they are \<19 or \>71 years, have an anticipated difficult airway, a body mass index \> 35kg.m-2 or are at risk of aspiration.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Publications (1)

• Acx E, Van Caelenberg E, De Baerdemaeker L, Coppens M. Laryngeal mask airway protector generates higher oropharyngeal leak pressures compared to the laryngeal mask airway supreme: A randomized clinical trial in the ambulatory surgery unit. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):221-225. doi: 10.4103/joacp.JOACP_416_19. Epub 2021 Jul 15.

  PMID: 34349370 DERIVED

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: July 26, 2017
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)