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Completed

NCT Number: NCT06245668

SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

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.

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Key information

Conditions

Anesthesia Airway

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SaCoVLM™ video laryngeal mask

Device

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

LMA Supreme

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  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.

  2. Peak Inspratuar Pressure and Plato Pressure

    Time frame: Intraoperative period

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

  3. 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

  4. Number of attempts to place the device

    Time frame: Intraoperative period

    Number of attempts needed for successful placement will be recorded.

  5. 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.

  6. 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.

  7. 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

  8. 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)

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 7, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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