Elderly, General Anesthesia, Laryngeal Mask Airway
Conditions
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.
Interventions
DEVICESaCoVLM™
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.
DEVICEAmbu®Auragain™
Patients will receive general anesthesia with their airways maintained with the Ambu Auragain, which is a conventional 2nd generation supraglottic airway device.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
95 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactJae Hoon Lee
Outcome results
None listed