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Clinical Trials/NCT04961814
NCT04961814
Completed
Not Applicable

Gastric Ultrasound Assessment of Two Preoperative Fasting Regimens in Pediatric Patients: a Randomized Clinical Trial.

Tanta University1 site in 1 country200 target enrollmentMarch 1, 2022
ConditionsAnesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Tanta University
Enrollment
200
Locations
1
Primary Endpoint
proportion of patients with a risky stomach.
Status
Completed
Last Updated
last year

Overview

Brief Summary

The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries

Detailed Description

it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting. There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography. hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
April 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mona Raafat Elghamry

principal investigator

Tanta University

Eligibility Criteria

Inclusion Criteria

  • paediatric patients aged 6-12 years old
  • ASA physical status I and II
  • scheduled for elective surgeries
  • the anticipated duration of 30-60 min

Exclusion Criteria

  • parents' refusal
  • overweight or obesity
  • expected difficult airway management
  • increased abdominal pressure
  • diabetes mellitus
  • congenital diseases
  • GERD or esophageal disease
  • uncooperative patients,
  • mental retardation or neurological disease
  • upper airway surgeries.

Outcomes

Primary Outcomes

proportion of patients with a risky stomach.

Time Frame: immediately preoperative

bedside ultrasound to estimate the gastric volume in milliliter

Secondary Outcomes

  • parents satisfaction(after PACU discharge (within 2 hours postoperative))
  • episodes of gastric regurgitation, vomiting , aspiration(during induction or emergence from anesthesia (within 30 minutes))
  • cancellation(decision will be taken within 30 minutes preoperative)
  • adverse events(preoperative or postoperative)
  • gastric volume(immediately preoperative (within 30 minutes))
  • gastric content quality(immediately preoperative)
  • type of last meal(last meal within 24 hours preoperative)
  • fasting hours(the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids))

Study Sites (1)

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