ElderlyNCT06237504
The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
A study testing SaCoVLM™ and Ambu®Auragain™ in people with Elderly and Laryngeal Mask Airway, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 95 years and older
- Conditions the study is for
- Elderly, Laryngeal Mask Airway, General Anesthesia
- What is being tested?
- SaCoVLM™ and Ambu®Auragain™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 95 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
Jae Hoon Lee, 82-2-2228-2418, neogens@yuhs.ac
About this study
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
- Being tested
- SaCoVLM™, Ambu®Auragain™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Ambu Auragain | Active comparator | Patients receiving general anesthesia with airway maintained with the 2nd generation SAD, Ambu Auragain. Receives: Device: Ambu®Auragain™ |
| SaCoVLM | Experimental | Patients receiving general anesthesia with airway maintained with the video LMA, SaCoVLM. Receives: Device: SaCoVLM™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Hoon Lee, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237504
- Sponsor's protocol ID
- 1-2023-0081
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)
- ClinicalTrials.gov ID
- NCT06237504
- Acronym / sponsor ID
- 1-2023-0081
- Conditions
- Elderly, Laryngeal Mask Airway, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu Auragain | Active comparator | Device: Ambu®Auragain™Patients receiving general anesthesia with airway maintained with the 2nd generation SAD, Ambu Auragain. |
| SaCoVLM | Experimental | Device: SaCoVLM™Patients receiving general anesthesia with airway maintained with the video LMA, SaCoVLM. |
Who may qualify
- Ages
- 95 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SaCoVLM |
| Ambu®Auragain™Patients will receive general anesthesia with their airways maintained with the Ambu Auragain, which is a conventional 2nd generation supraglottic airway device. | Device | Ambu Auragain |
Primary outcome
Success of SAD insertion on first attempt.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Hoon Lee principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaCoVLM™ and Ambu®Auragain™ in people with Elderly and Laryngeal Mask Airway, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Hoon Lee (82-2-2228-2418, neogens@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of SAD insertion on first attempt. (time frame: Within the intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.