Preoperative Pediatric Fasting Regimens

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: standard fasting; Other: liberal fasting

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Tanta University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child, Adult)
• Accepts Healthy Volunteers: No

Study Population

paediatric patients aged 6-12 years old,both sex, ASA physical status I and II

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard fasting; preoperative fasting according to 6-4-2 regimen then preoperative bedside gastric ultrasound assessment will be done	Other: standard fasting; preoperative fasting according to 6-4-2 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach
Experimental: liberal fasting; preoperative fasting according to 6-4-0 regimen then preoperative bedside gastric ultrasound assessment will be done	Other: liberal fasting; preoperative fasting according to 6-4-0 regimen then qualitative and quantitative preoperative gastric ultrasound assessment will be done to evaluate the proportion of patients with risky stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients with a risky stomach.	bedside ultrasound to estimate the gastric volume in milliliter	immediately preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastric content quality	bedside ultrasound to determine the nature of gastric content (solid or fluid)	immediately preoperative
fasting hours	actual and prescribed preoperative fasting	the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)
type of last meal	last meal (heavy solid,light solid,non clear fluid,or clear fluid)	last meal within 24 hours preoperative
episodes of gastric regurgitation, vomiting , aspiration	incidence of regurgitation, vomiting , aspiration if regurgitation happened patients will be followed up postoperative clinically and radiologically	during induction or emergence from anesthesia (within 30 minutes)
gastric volume	quantitative gastric ultrasound assessment (gastric volume, volume/weight, antral cross sectional area)	immediately preoperative (within 30 minutes)
parents satisfaction	parents' satisfaction is evaluated using a 5-point Likert scale	after PACU discharge (within 2 hours postoperative)
cancellation	rate of surgery cancellation	decision will be taken within 30 minutes preoperative
adverse events	adverse events related to fasting duration	preoperative or postoperative

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mona R Elghamry, MD, Tanta University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: June 5, 2021
• First Submitted That Met QC Criteria: July 3, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB No: 34601/4/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: statistics of demographic data, gastric volume, fasting hours, type of last meal, episode of gastric regurgitation
• IPD Sharing Time Frame: the IPD will be shared after finishing and publication of the study and it will be available for 6 months
• IPD Sharing Access Criteria: the IPD will be available for scientific research only upon e-mail request which will be sent to principal investigator (drmonagh19802000@gmail.com)
• IPD Sharing Supporting Information Type: SAP

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.: Yes