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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-08-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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higher pressure

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

Group Type PLACEBO_COMPARATOR

higher pressure

Intervention Type BEHAVIORAL

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

lower pressure

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

Group Type EXPERIMENTAL

lower pressure

Intervention Type BEHAVIORAL

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

Interventions

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lower pressure

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

Intervention Type BEHAVIORAL

higher pressure

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No