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

Not Applicable

Recruiting

• Conditions: General Anesthesia; Elderly; Laryngeal Mask Airway
• Interventions: Device: Ambu®Auragain™; Device: SaCoVLM™

• Registration Number: NCT06237504
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study Start: 2024-02
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu Auragain	Ambu®Auragain™	Patients receiving general anesthesia with airway maintained with the 2nd generation SAD, Ambu Auragain.
SaCoVLM	SaCoVLM™	Patients receiving general anesthesia with airway maintained with the video LMA, SaCoVLM.

Primary Outcome Measures

Name	Time	Method
Success of SAD insertion on first attempt.	Within the intraoperative period	The success of SAD insertion is defined as when the a normal square-shaped capnography waveform is detected upon manual ventilation and symmetric movements of the patient's chest wall are observed.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of