Ultrasound for Prediction of Empty Stomach in Infants

December 12, 2022 updated by: Feyza Sever, Ankara City Hospital Bilkent

The Relationship Between Gastric Ultrasound Findings and Endoscopically Aspirated Volume in Infants and Determination of Antral Cut-off Value for the Diagnosis of Empty Stomach

Background and Aim: Pulmonary aspiration of gastric content is a serious perioperative complication. What is known about the pediatric patient's fasting time is usually based on parental history alone, but in some situation there may be doubts about an empty stomach in young children. Ultrasound examination of the gastric antrum is increasingly used and is emerging as a valuable perioperative noninvasive tool for the indirect assessment of gastric volumes in children. The objective of this prospective study was to assess the relationship between the cross-sectional area (CSA) of the antrum measured by gastric ultrasound and gastric volumes suctioned endoscopically, also to determine the best cut-off value of CSA for empty antrum in the pediatric population less than 24 months of age.

Study Overview

Status

Status

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

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.

Detailed Description

Protocol: This study was performed in Pediatric Gastrointestinal (GI) Endoscopy Unit after receiving Institutional Ethics Board approval. Following induction of anaesthesia, antral sonography was performed in supine and right lateral decubitus (RLD) positions in 46 fasted infants prior to upper GI endoscopic evaluation. Antral CSA measurements in both positions and the qualitative evaluation of the antrum (according to the 3-point grading system) were recorded. Grade 0: antrum appears empty in both positions. Grade 1: antrum appears empty in the supine position but a small volume of gastric clear fluid is visible in the RLD. Grade 2: antral clear fluid visualized in both the supine and RLD position. The calculation of the antral CSA was performed by measuring the longitudinal diameter (D1) and the antero-posterior diameter (D2) of the antrum at rest, between peristaltic contractions, from serosa to serosa. Cross-sectional area was calculated using the standard formula for surface area of an ellipse CSA= π x D1 x D2 / 4. Gastric contents were endoscopically suctioned and measured by a graduated specimen trap with 1 ml increments.

Sample size A sample of 23 from the positive group and 23 from the negative group achieve 80% power to detect a difference of 0,2300 between the area under the receiver operating characteristic (ROC) curve (AUC) under the null hypothesis of ,5000 and an AUC under the alternative hypothesis of 0,7300 using a two-sided z-test at a significance level of 0,05000. The data are continuous responses. The AUC is computed between false positive rates of 0,000 and 1,000. The ratio of the standard deviation of the responses in the negative group to the standard deviation of the responses in the positive group is 1,000.

Statistical analysis:

All statistical analysis was performed using IBM SPSS for Windows Version 23.0 software. Descriptive statistics for continuous variables were shown as mean ± standard deviation (SD) or median [inter-quartile range (IQR); 25-75th percentile]. Categorical variables were shown as the number of patients and percentage (%). Whether the distributions of continuous variables were normal or not was determined by the Shapiro Wilks test. Correlations between continuous variables were given by Spearman Correlation Coefficient. Discriminative ability of the CSA was determined by ROC curve analysis. Optimal cut-off value was given by Youden index. Sensitivity, specificity, positive and negative predictive value were calculated at this point. A p value less than 0.05 was considered statistically significant.

Stepwise linear regression analysis was applied to estimate CSA. The variables those p values <0.20 in the univariate analysis were included in multiple regression model. The independent variables were determined as age, BMI and CSA-RLD. The adequacy of the established regression models was demonstrated by R2.

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.
Observational

Enrollment (Actual)

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.
46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06800
        • Feyza Sever

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

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants (< 24 months age) undergoing elective upper GI endoscopy

Description

Inclusion Criteria:

  • All infants (< 24 months age) undergoing elective upper GI endoscopy under general anesthesia and American Society of Anesthesiology (ASA) physical status I -II, were included in this study

Exclusion Criteria:

  • Parental refusal
  • Previous lower esophageal or gastric surgery
  • Non-adherence with the fasting regimen
  • More than 5 minutes between gastric sonography and endoscopy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group 1 (Patients who recorded as Grade 0)

Patients whose antrum appears empty in supine and right lateral decubitus (RLD) positions by gastric ultrasound (Grade 0). Groups are classified according to the qualitative evaluation of the antrum by gastric sonographic examination.

The nature of the gastric contents (empty, clear liquid, dark liquid/solid) is established based on the qualitative findings by gastric antral ultrasonography. The qualitative evaluation of the antrum was recorded according to the 3-point grading system as Grade 0, Grade 1, and Grade 2.

Grade 0: antrum appears empty in both positions. Grade 1: antrum appears empty in the supine position but a small volume of gastric clear fluid is visible in the RLD position.

Grade 2: antral clear fluid visualized in both the supine and RLD position
Other: Group 1 (Patients who recorded as Grade 0)
When the gastric contents were evaluated with the upper gastrointestinal endoscopy, the stomach was completely empty in Group 1 that patients who recorded as Grade 0.
Group 2 ( Patients who recorded as Grade 1)

Patients whose antrum appears empty in the supine position but a small volume of gastric clear fluid is visible in the RLD position by gastric ultrasound (Grade 1). Groups are classified according to the qualitative evaluation of the antrum by gastric sonographic examination The nature of the gastric contents (empty, clear liquid, dark liquid/solid) is established based on the qualitative findings by gastric antral ultrasonography. The qualitative evaluation of the antrum was recorded according to the 3-point grading system as Grade 0, Grade 1, and Grade 2.

Grade 0: antrum appears empty in both positions. Grade 1: antrum appears empty in the supine position but a small volume of gastric clear fluid is visible in the RLD position.

Grade 2: antral clear fluid visualized in both the supine and RLD position
Other: Group 2 ( Patients who recorded as Grade 1)
When the gastric contents were evaluated with the endoscope, small volume of gastric clear fluid was visible and gastric content aspirated and measured in Group 2 that patients who recorded as Grade 1.

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
The best cut-off value of CSA for an empty antrum
Time Frame: 30 minutes
The investigators wanted to determine the best cut-off value of CSA for a truly empty antrum in the pediatric population less than 24 months of age
30 minutes
The relationship between antral cross-sectional area and aspirated gastric volumes
Time Frame: 30 minutes
The investigators wanted to evaluate the correlation between sonographically measured gastric antral CSA in both supine and RLD positions, and gastric volume suctioned under direct endoscopic visualization in infants between 0-24 months age.
30 minutes

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
A mathematical model for gastric volume estimation
Time Frame: 30 minutes
The investigators wanted to generate a final predictive model for gastric volume estimation in infants.
30 minutes

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.
Ankara City Hospital Bilkent

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 (Actual)

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.
November 1, 2021

Primary Completion (Actual)

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.
June 30, 2022

Study Completion (Actual)

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.
June 30, 2022

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).
November 24, 2022

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.
November 24, 2022

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.
December 6, 2022

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.
December 14, 2022

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.
December 12, 2022

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.
November 1, 2022

More Information

Terms related to this study

Keywords

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.
  • E2-21-490

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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