Ultrasound for Prediction of Empty Stomach in Infants

NCT05637918 | Completed

• 1 other identifier: E2-21-490
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Children, Only; Pulmonary Aspiration; Anesthesia; Fasting

Keywords

Gastric ultrasound; Infant; Upper gastrointestinal endoscopy; Empty stomach

Outcome Measures

Primary Outcomes (2)

• The relationship between antral cross-sectional area and aspirated gastric volumes

  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

• The best cut-off value of CSA for an empty antrum

  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

Secondary Outcomes (1)

• A mathematical model for gastric volume estimation

  30 minutes

Study Arms (2)

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)

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)

Interventions

Group 1 (Patients who recorded as Grade 0) OTHER

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 1 (Patients who recorded as Grade 0)

Group 2 ( Patients who recorded as Grade 1) OTHER

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.

Group 2 ( Patients who recorded as Grade 1)

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Feyza Sever

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Feyza Sever

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 6, 2022
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-11

Locations

TU (1)