LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

Ondokuz Mayıs University

Status: Completed

Conditions: Airway; Anesthesia

Treatments: Procedure: Group 2; Procedure: Group 3; Procedure: Group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT06174896

LMAPR1955

Details and patient eligibility

About

Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.

Full description

LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications.

Our research is a prospective, randomized controlled method study.

Patients will be divided into 3 groups.

Group 1:(Standard technique)

Group 2:(Placement with direct laryngoscopy)

Group 3:(Placement with the aid of video laryngoscopy)

After LMA Proseal 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: 150 patients

Sex: All

Ages: 1 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1-10 years old
• Between 5-40 kg
• ASA (American Society of Anesthesiologists) physical score I/II
• Cases undergoing elective surgery lasting less than 90 minutes

Exclusion criteria

• Patients who are expected to have a difficult airway
• Those with potential regurgitation risk (severe GER, 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 who need muscle relaxants
• Presence of intraoral abscess, pharyngeal pathology
• Those who have had an upper or lower respiratory tract infection in the last 4 weeks
• History of allergy to the drugs to be used
• Failure of patients and their relatives to give consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Placement with standard technique

Treatment:

Procedure: Group 1

Group 2

Active Comparator group

Description:

Placement with direct laryngoscopy

Treatment:

Procedure: Group 2

Group 3

Active Comparator group

Description:

Placement with the aid of video laryngoscopy

Treatment:

Procedure: Group 3