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

July 31, 2020 updated by: Jin-Tae Kim, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of gastric insufflation(antrum)
Time Frame: During the surgery(up to 3 hours)
Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound
During the surgery(up to 3 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The size of gastric antrum and body
Time Frame: 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
During the surgery(up to 3 hours)
Time for insertion of LMA flexible
Time Frame: During the anesthesia induction(up to 1 hour)
Time for insertion of LMA flexible
During the anesthesia induction(up to 1 hour)
Success rate of insertion of LMA flexible
Time Frame: 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
Time Frame: 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
Time Frame: During the surgery(up to 3 hours)
The number and the type of additional manipulation for successful ventilation
During the surgery(up to 3 hours)
Ease of insertion of LMA flexible
Time Frame: During the anesthesia induction(up to 1 hour)
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)
Time Frame: During the surgery(up to 3 hours)
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
Time Frame: During the surgery(up to 3 hours)
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
Time Frame: During the surgery(up to 3 hours)
peak pressure observed before, during, after surgery
During the surgery(up to 3 hours)
oropharyngeal leak pressure
Time Frame: 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
During the surgery(up to 3 hours)
the complication rate
Time Frame: 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
During the surgery and after surgery (up to 6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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