Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05637918 |
| Other study ID # |
E2-21-490 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Ankara City Hospital Bilkent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
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.
