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

NCT ID: NCT06237504

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2026-01-31

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.

Conditions

Elderly; Laryngeal Mask Airway; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Ambu Auragain

Patients receiving general anesthesia with airway maintained with the 2nd generation SAD, Ambu Auragain.

Group Type: ACTIVE_COMPARATOR

Ambu®Auragain™

Intervention Type: DEVICE

Patients will receive general anesthesia with their airways maintained with the Ambu Auragain, which is a conventional 2nd generation supraglottic airway device.

SaCoVLM

Patients receiving general anesthesia with airway maintained with the video LMA, SaCoVLM.

Group Type: EXPERIMENTAL

SaCoVLM™

Intervention Type: DEVICE

Patients will receive general anesthesia with their airways maintained with the SaCoVLM, which is a newer supraglottic airway device with a video port to directly visualize the upper airway.

Interventions

SaCoVLM™

Patients will receive general anesthesia with their airways maintained with the SaCoVLM, which is a newer supraglottic airway device with a video port to directly visualize the upper airway.

Intervention Type: DEVICE

Ambu®Auragain™

Patients will receive general anesthesia with their airways maintained with the Ambu Auragain, which is a conventional 2nd generation supraglottic airway device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Hoon Lee

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Locations

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jae Hoon Lee

Role: CONTACT

neogens@yuhs.ac

82-2-2228-2418

Facility Contacts

Jae Hoon Lee

Role: primary

neogens@yuhs.ac

82-2-2228-2418

Other Identifiers

1-2023-0081

Identifier Type: -

Identifier Source: org_study_id