SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

December 26, 2024 updated by: BURHAN DOST, Ondokuz Mayıs University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55270
        • Ondokuz Mayis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SaCoVLM™ video laryngeal mask
Device: SaCoVLM™ video laryngeal mask
The SaCoVLM™ video laryngeal mask will be placed directly into the hypopharyngeal space until resistance is felt, following the recommended instructions for use.
Active Comparator: LMA Supreme
Device: LMA Supreme
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal leak pressure
Time Frame: Immediately after the laryngeal mask is placed, before start of surgery

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion time
Time Frame: 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.)
Insertion time will be the time between picking up the device and successful placement
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.)
Number of attempts to place the device
Time Frame: Intraoperative period
Number of attempts needed for successful placement will be recorded.
Intraoperative period
Blood pressure
Time Frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Non-invasive blood pressure will measure blood pressure in millimeters of mercury.
Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Heart rate
Time Frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Heart rate will be measured in beats per minute with an electrocardiography monitor.
Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Peripheral oxygen saturation
Time Frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Peripheral oxygen saturation per minute will be measured by pulse oximetry
Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Complications
Time Frame: Intraoperative and postoperative day 1.
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)
Intraoperative and postoperative day 1.
Assessment of Glottis Visualization Scores
Time Frame: Intraoperative period after the LMA insertion
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.
Intraoperative period after the LMA insertion
Peak Inspratuar Pressure and Plato Pressure
Time Frame: Intraoperative period
Peak Inspratuar Pressure and Plato Pressure will be measured after the OLP measurement
Intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Study Director: Burhan Dost, Assoc. Prof., Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 26, 2024

Study Completion (Actual)

December 25, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VLMSM5455

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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