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The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)

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Yonsei University

Status

Enrolling

Conditions

Laryngeal Mask Airway
General Anesthesia
Elderly

Treatments

Device: SaCoVLM™
Device: Ambu®Auragain™

Study type

Interventional

Funder types

Other

Identifiers

NCT06237504
1-2023-0081

Details and patient eligibility

About

This study aims to investigate whether the use of a video LMA device (SacoVLM™) will facilitate successful supraglottic airway device (SAD) insertion compared to the use of a conventional 2nd generation SAD (Ambu®Auragain™) in elderly patients. This study is a randomized trail with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.

Enrollment

140 estimated patients

Sex

All

Ages

95+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients 65 years of age or older, ASA class I~III, scheduled for elective surgery under general anesthesia under 2 hours, and eligible for SAD use for airway maintenance.

Exclusion criteria

Refusal to participate, patients unable to read consent form, anticipated difficulty in face mask ventilation or airway management based on past history or anatomical structure, upper respiratory tract infection, airway-related diseases such as asthma or pneumonia, risk of gastroesophageal reflux

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

140 participants in 2 patient groups

Ambu Auragain
Active Comparator group
Description:
Patients receiving general anesthesia with airway maintained with the 2nd generation SAD, Ambu Auragain.
Treatment:
Device: Ambu®Auragain™
SaCoVLM
Experimental group
Description:
Patients receiving general anesthesia with airway maintained with the video LMA, SaCoVLM.
Treatment:
Device: SaCoVLM™

Trial contacts and locations

1

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Central trial contact

Jae Hoon Lee

Data sourced from clinicaltrials.gov

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