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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04494802
• Collaborator: (none)
• Enrollment: 230
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspiration	Behavioral: lower pressure; Behavioral: higher pressure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients
• Anticipated Study Start Date: Aug 10, 2020
• Anticipated Primary Completion Date: Aug 10, 2021
• Anticipated Study Completion Date: Aug 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Time for insertion of LMA flexible [During the anesthesia induction(up to 1 hour)]

   Time for insertion of LMA flexible

3. Success rate of insertion of LMA flexible [During the anesthesia induction(up to 1 hour)]

   Success rate of insertion of LMA flexible

4. The number of insertion attempt [During the anesthesia induction(up to 1 hour)]

   The number of insertion attempt

5. 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

6. 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)

7. Incidence of gastric insufflation(body) [During the surgery(up to 3 hours)]

   Incidence of gastric insufflation which was recognized in gastric body with ultrasound

8. 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

9. peak pressure observed before, during, after surgery [During the surgery(up to 3 hours)]

   peak pressure observed before, during, after surgery

10. 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

11. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04494802
• Other Study ID Numbers: Gastric insufflation
• First Posted: Jul 31, 2020
• Last Update Posted: Aug 4, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 4, 2020