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

The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients

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.

Study Overview

• Status: Unknown
• Conditions: Aspiration
• Intervention / Treatment: Behavioral: higher pressure; Behavioral: lower pressure

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: higher pressure; During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O	Behavioral: higher pressure; During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
EXPERIMENTAL: lower pressure; During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O	Behavioral: lower pressure; During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of gastric insufflation(antrum)	Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound	During the surgery(up to 3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The size of gastric antrum and body	The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery	During the surgery(up to 3 hours)
Time for insertion of LMA flexible	Time for insertion of LMA flexible	During the anesthesia induction(up to 1 hour)
Success rate of insertion of LMA flexible	Success rate of insertion of LMA flexible	During the anesthesia induction(up to 1 hour)
The number of insertion attempt	The number of insertion attempt	During the anesthesia induction(up to 1 hour)
The number and the type of additional manipulation for successful ventilation	The number and the type of additional manipulation for successful ventilation	During the surgery(up to 3 hours)
Ease of insertion of LMA flexible	Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult)	During the anesthesia induction(up to 1 hour)
Incidence of gastric insufflation(body)	Incidence of gastric insufflation which was recognized in gastric body with ultrasound	During the surgery(up to 3 hours)
Incidence of gastric insufflation recognized with the ausculation	Incidence of gastric insufflation recognized with the ausculation after finishing surgery	During the surgery(up to 3 hours)
peak pressure observed before, during, after surgery	peak pressure observed before, during, after surgery	During the surgery(up to 3 hours)
oropharyngeal leak pressure	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	During the surgery(up to 3 hours)
the complication rate	the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration	During the surgery and after surgery (up to 6 hours)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 10, 2020
• Primary Completion (ANTICIPATED): August 10, 2021
• Study Completion (ANTICIPATED): August 10, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (ACTUAL): July 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Gastric insufflation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No