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

Not Applicable

• Conditions: Aspiration
• Interventions: Behavioral: higher pressure; Behavioral: lower pressure

• Registration Number: NCT04494802
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04
• Study Start: 2020-08-10
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
higher pressure	higher pressure	During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
lower pressure	lower pressure	During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O

Primary Outcome Measures

Name	Time	Method
Incidence of gastric insufflation(antrum)	During the surgery(up to 3 hours)	Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound

Secondary Outcome Measures

Name	Time	Method
oropharyngeal leak pressure	During the surgery(up to 3 hours)	oropharyngeal leak pressure will be assessed by setting the APL valve of the circle system at 30 cmH2O with fresh gas flow of 3 L/min after the surgery
the complication rate	During the surgery and after surgery (up to 6 hours)	the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration
Success rate of insertion of LMA flexible	During the anesthesia induction(up to 1 hour)	Success rate of insertion of LMA flexible
The size of gastric antrum and body	During the surgery(up to 3 hours)	The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery
peak pressure observed before, during, after surgery	During the surgery(up to 3 hours)	peak pressure observed before, during, after surgery
The number and the type of additional manipulation for successful ventilation	During the surgery(up to 3 hours)	The number and the type of additional manipulation for successful ventilation
Time for insertion of LMA flexible	During the anesthesia induction(up to 1 hour)	Time for insertion of LMA flexible
The number of insertion attempt	During the anesthesia induction(up to 1 hour)	The number of insertion attempt
Ease of insertion of LMA flexible	During the anesthesia induction(up to 1 hour)	Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult)
Incidence of gastric insufflation recognized with the ausculation	During the surgery(up to 3 hours)	Incidence of gastric insufflation recognized with the ausculation after finishing surgery
Incidence of gastric insufflation(body)	During the surgery(up to 3 hours)	Incidence of gastric insufflation which was recognized in gastric body with ultrasound