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

Aspiration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04494802
• Other study ID #: Gastric insufflation
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, PhD
• Phone: 82-2-2072-3664
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration

Intervention

Behavioral:
• lower pressure
During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
• higher pressure
During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Time for insertion of LMA flexible	Time for insertion of LMA flexible	During the anesthesia induction(up to 1 hour)
Secondary	Success rate of insertion of LMA flexible	Success rate of insertion of LMA flexible	During the anesthesia induction(up to 1 hour)
Secondary	The number of insertion attempt	The number of insertion attempt	During the anesthesia induction(up to 1 hour)
Secondary	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)
Secondary	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)
Secondary	Incidence of gastric insufflation(body)	Incidence of gastric insufflation which was recognized in gastric body with ultrasound	During the surgery(up to 3 hours)
Secondary	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)
Secondary	peak pressure observed before, during, after surgery	peak pressure observed before, during, after surgery	During the surgery(up to 3 hours)
Secondary	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)
Secondary	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)