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AnesthesiaNCT06245668

SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

A study testing SaCoVLM™ video laryngeal mask and LMA Supreme in people with Anesthesia and Airway, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our study aimed to compare two different laryngeal masks, SaCoVLM™ Video Laryngeal Mask and blind placement with LMA Supreme, in adult patients undergoing short elective surgeries. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anesthesia, Airway
What is being tested?
SaCoVLM™ video laryngeal mask and LMA Supreme
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 25 Dec 2024
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years
  • BMI < 35 kg/m2
  • ASA (American Society of Anesthesiologists) physical score I/II
  • Elective surgeries lasting less than 90 minutes

Who cannot join

  • Patients who are expected to have a difficult airway
  • Those with potential risk of regurgitation (severe reflux, presence of hiatal hernia)
  • Those who will undergo head and neck surgery, laparoscopic surgery
  • Those who will undergo surgery in the prone position
  • Emergency surgical interventions
  • Those requiring muscle relaxants
Show all 10Show fewer
  • Presence of oral abscess, pharyngeal pathology
  • Those who have had an upper or lower respiratory tract infection in the last 4 weeks
  • History of allergy to medications used
  • Failure to obtain the consent of patients or their families

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ondokuz Mayis University

    Samsun, 55270

Other trials in Turkey (Türkiye)

About this study

Official title: The Comparison of SaCoVLM™ Video Laryngeal Mask and LMA Supreme in Terms of Oropharyngeal Leak Pressure

Our study aimed to compare two different laryngeal masks, SaCoVLM™ Video Laryngeal Mask and blind placement with LMA Supreme, in adult patients undergoing short elective surgeries. The aim is to optimize the use of commonly used laryngeal masks in clinical practice and examine the differences in oropharyngeal leak pressures.

Read the detailed description

Laryngeal masks are alternative airway devices commonly used in anesthesia, serving both spontaneously breathing and ventilated patients. LMA Supreme, a second-generation laryngeal mask, has been widely used in routine anesthesia practices and short-duration procedures in our clinic. The advantage of second-generation masks is the presence of gastric access pathways, allowing for additional decompression of the stomach. SaCoVLM™ Video Laryngeal Mask also features a gastric access pathway. Placement of laryngeal masks requires attention to the anatomical features of the airway. Unsuccessful placement of a laryngeal mask can lead to issues such as throat pain, hoarseness, difficulty swallowing, airway obstruction, or leakage, as well as an increase in intragastric pressure due to gastric distention.

Our research is a prospective, randomized, controlled method study.The aim in this study is to reveal most accurate placement technique and device to transfer this method to clinical applications. Patients will be evaluated in two groups.

Group 1: Placement with SaCoVLM™ video laryngeal mask Group 2: Placement of the LMA Supreme with standard technique

After LMA Supreme and SaCoVLM™ video laryngeal mask placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.

Conditions
Anesthesia, Airway
Being tested
SaCoVLM™ video laryngeal mask, LMA Supreme
Keywords
Supraglottic airway device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaCoVLM™ video laryngeal maskDevice

    The SaCoVLM™ video laryngeal mask will be placed directly into the hypopharyngeal space until resistance is felt, following the recommended instructions for use.

  • LMA SupremeDevice

    The LMA Supreme will be inserted directly by hand and placed into the hypopharyngeal space until resistance is felt, as per the recommended instructions for use.

Study groups in NCT06245668
Study groupRoleWhat they receive
SaCoVLM™ video laryngeal maskActive comparatorSaCoVLM™ video laryngeal mask
Receives: Device: SaCoVLM™ video laryngeal mask
LMA SupremeActive comparatorLMA Supreme
Receives: Device: LMA Supreme

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oropharyngeal leak pressure

    Oropharyngeal leak pressure (OLP) will be measured by closing the adjustable pressure limiting valve on the anesthesia machine. The fresh gas flow was adjusted to 4 L/min. When the APL (Adjustable pressure limiting) valve was closed and manually ventilated. The leak sound that occurs during ventilation will be auscultated. The first peak airway pressure at which the leak occurs will be recorded as the oropharyngeal leak pressure.

    After successful insertion, laryngeal mask location will be evaluated with fiberoptic imaging.

    Measured: Immediately after the laryngeal mask is placed, before start of surgery

Secondary outcomes (8)

  1. Assessment of Glottis Visualization Scores

    This will be assessed using five stages; Stage 1: Vocal cords not visible. Stage 2: Vocal cords and anterior epiglottis visible. Stage 3: Vocal cords and posterior epiglottis visible. Stage 4: Only vocal cords visible.

    Measured: Intraoperative period after the LMA insertion

  2. Peak Inspratuar Pressure and Plato Pressure

    Peak Inspratuar Pressure and Plato Pressure will be measured after the OLP measurement

    Measured: Intraoperative period

  3. Insertion time

    Insertion time will be the time between picking up the device and successful placement

    Measured: Procedure (Time from LMA handling to first wave formation in capnography, assessed from the initiation of LMA handling until the detection of the first capnography wave.)

  4. Number of attempts to place the device

    Number of attempts needed for successful placement will be recorded.

    Measured: Intraoperative period

  5. Blood pressure

    Non-invasive blood pressure will measure blood pressure in millimeters of mercury.

    Measured: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

  6. Heart rate

    Heart rate will be measured in beats per minute with an electrocardiography monitor.

    Measured: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

  7. Peripheral oxygen saturation

    Peripheral oxygen saturation per minute will be measured by pulse oximetry

    Measured: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

  8. Complications

    The presence of complications that may be encountered after LMA removal will be investigated (Cough, Bucking, Laryngospasm, Aspiration, Desaturation(SpO2%< 90%), Need airway assist device(Nasal or oral airway), Blood on the surface of the cuff, hoarseness,sore throat)

    Measured: Intraoperative and postoperative day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start1 Apr 2024
  3. Primary completion26 Oct 2024
  4. Study completion25 Dec 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer ('Urbaniak and Plous 2013')'.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06245668
Sponsor's protocol ID
VLMSM5455
Status last verified
Dec 2024
First submitted
29 Jan 2024
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.

    PubMed 28870163

  • Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available.

    PubMed 28510747

  • Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. Comparison of SaCoVLM video laryngeal mask-guided intubation and i-gel combined with flexible bronchoscopy-guided intubation in airway management during general anesthesia: a non-inferiority study. BMC Anesthesiol. 2022 Sep 22;22(1):302. doi: 10.1186/s12871-022-01843-x.

    PubMed 36138363

  • Belena JM, Nunez M, Anta D, Carnero M, Gracia JL, Ayala JL, Alvarez R, Yuste J. Comparison of Laryngeal Mask Airway Supreme and Laryngeal Mask Airway Proseal with respect to oropharyngeal leak pressure during laparoscopic cholecystectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Mar;30(3):119-23. doi: 10.1097/EJA.0b013e32835aba6a.

    PubMed 23318811

  • Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. To compare the influence of blind insertion and up-down optimized glottic exposure manoeuvre on oropharyngeal leak pressure using SaCoVLM video laryngeal mask among patients undergoing general anesthesia. J Clin Monit Comput. 2023 Apr;37(2):593-598. doi: 10.1007/s10877-022-00930-1. Epub 2022 Oct 29.

    PubMed 36308611

  • Ozden GG, Dost B, Kaya C, Turunc E, Koksal E, Ustun YB, Bilgin S, Baris S. Comparison of oropharyngeal leak pressure between the SaCoVLM video laryngeal mask and LMA supreme in adult elective surgery patients: a prospective randomized controlled trial. BMC Anesthesiol. 2025 Jul 3;25(1):334. doi: 10.1186/s12871-025-03218-4.

    PubMed 40610857

Questions about this trial

What is this clinical trial studying?

A study testing SaCoVLM™ video laryngeal mask and LMA Supreme in people with Anesthesia and Airway, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

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 4 inclusion and 10 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: finished, as of the sponsor's last update on 30 Dec 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oropharyngeal leak pressure (time frame: Immediately after the laryngeal mask is placed, before start of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06245668, which also lists 6 linked publications.

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 30 Dec 2024.

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