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

NCT06237504 | Unknown

• 1 other identifier: 1-2023-0081
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Success of SAD insertion on first attempt.

  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.

  Within the intraoperative period

Study Arms (2)

Ambu Auragain

ACTIVE COMPARATOR

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

Device: Ambu®Auragain™

SaCoVLM

EXPERIMENTAL

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

Device: SaCoVLM™

Interventions

SaCoVLM™ 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.

SaCoVLM

Ambu®Auragain™ DEVICE

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

Ambu Auragain

Eligibility Criteria

• Age: 95 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

Study Officials

• Jae Hoon Lee

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Hoon Lee

CONTACT

82-2-2228-2418; neogens@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)