The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient

Seoul National University

Status: Unknown

Conditions: Aspiration

Treatments: Behavioral: lower pressure; Behavioral: higher pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04494802

Gastric insufflation

Details and patient eligibility

About

Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low will not increase gastric insufflation and there is no change in other outcome variables, keeping it low may have a positive effect on anesthesia management and outcome in children.

Enrollment: 230 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pediatric patients undergoing general anesthesia with LMA flexible

Exclusion criteria

• Unstable vital sign, significant arrhythmia or hypotension, Shock
• anticipated difficult intubation or the patient who have facial deformity
• high risk of aspiration
• recent upper respiratory tract infection history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups, including a placebo group

higher pressure

Placebo Comparator group

Description:

During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O

Treatment:

Behavioral: higher pressure

lower pressure

Experimental group

Description:

During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O

Treatment:

Behavioral: lower pressure