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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06237504
Other study ID # 1-2023-0081
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date January 2026

Study information

Verified date January 2024
Source Yonsei University
Contact Jae Hoon Lee
Phone 82-2-2228-2418
Email neogens@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 95 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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