Comparing a video laryngeal mask to a conventional airway device in elderly patients
The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
This study tests whether a new video laryngeal mask can help manage airways better than a standard device in older patients having short surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 95 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06237504 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the SaCoVLM™ video laryngeal mask airway device compared to the conventional Ambu®Auragain™ device in facilitating airway management during general anesthesia in elderly patients. It is a randomized trial where participants have a 50% chance of being assigned to either device group. An anesthesiologist, who is not involved in the anesthesia or postoperative assessment, will perform randomization, and both patients and outcome assessors will be blinded to the group assignments. The focus is on patients aged 65 and older undergoing elective surgery lasting less than two hours.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older, classified as ASA class I-III, scheduled for elective surgery under general anesthesia.
Not a fit: Patients with a history of airway-related diseases, upper respiratory infections, or those at risk for gastroesophageal reflux may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve airway management and safety during anesthesia in elderly patients.
How similar studies have performed: Other studies have shown varying success with similar airway management devices, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jae Hoon Lee — Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
- Study coordinator: Jae Hoon Lee
- Email: neogens@yuhs.ac
- Phone: 82-2-2228-2418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.