SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

Ondokuz Mayıs University

Status: Enrolling

Conditions: Airway; Anesthesia

Treatments: Device: SaCoVLM™ video laryngeal mask; Device: LMA Supreme

Study type: Interventional

Funder types: Other

Identifiers

NCT06245668

VLMSM5455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

164 participants in 2 patient groups

SaCoVLM™ video laryngeal mask

Active Comparator group

Description:

SaCoVLM™ video laryngeal mask

Treatment:

Device: SaCoVLM™ video laryngeal mask

LMA Supreme

Active Comparator group

Description:

LMA Supreme

Treatment:

Device: LMA Supreme