The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient
1 other identifier
interventional
230
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedAugust 4, 2020
July 1, 2020
1 year
July 28, 2020
July 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
The size of gastric antrum and body
During the surgery(up to 3 hours)
Time for insertion of LMA flexible
During the anesthesia induction(up to 1 hour)
Success rate of insertion of LMA flexible
During the anesthesia induction(up to 1 hour)
The number of insertion attempt
During the anesthesia induction(up to 1 hour)
The number and the type of additional manipulation for successful ventilation
During the surgery(up to 3 hours)
- +6 more secondary outcomes
Study Arms (2)
higher pressure
PLACEBO COMPARATORDuring the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
lower pressure
EXPERIMENTALDuring the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
Interventions
During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
Eligibility Criteria
You may qualify if:
- pediatric patients undergoing general anesthesia with LMA flexible
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 28, 2020
First Posted
July 31, 2020
Study Start
August 10, 2020
Primary Completion
August 10, 2021
Study Completion
August 10, 2021
Last Updated
August 4, 2020
Record last verified: 2020-07