The Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound

Evaluation of the Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound: a Randomized Controlled Trial

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound.

The investigators hypothesize that gastric emptying in children might be faster if the patient is in semi-sitting position. This hypothesis could impact the current guidelines for peri-operative fasting. Moreover, if this proved effective, could be used for enhancement of gastric emptying before emergency operations in non-fasting patient.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Fasting
• Intervention / Treatment: Other: Supine position; Other: Semi-sitting position

Detailed Description

Dealing with preoperative fasting requires a meticulous balance ensuring patient safety and lessening patient's discomfort. Although fasting is a basic requirement for avoiding pulmonary aspiration, it is sometimes associated with patient discomfort and hypoglycemia. According to the current guidelines for preoperative fasting of children, fasting is required for 2-hours, 4-hours, and 6-hours period after ingestion of water, breast milk, and infant formula respectively. Limited data is available for the effect of patient positioning on gastric emptying. A previous study had reported that gastric emptying of non-nutrient liquids was faster in the sitting position compared with the left lateral position . Another study showed similar findings after nutritive liquid and solid meals; whilst, a third study had reported that gravity has a little effect on gastric emptying.

In pediatric population the effect of posture on the duration of gastric emptying is not well investigated.

Gastric ultrasound is a valid, accurate, reproducible, non-invasive, bedside test for evaluation of the gastric volume. gastric ultrasound has been validated in adults as well as children for estimating the volume of gastric contents and evaluating gastric emptying.

The aim of this work is to evaluate the effect of semi sitting versus supine positions on gastric emptying of fluids in children using gastric ultrasound.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Ahmed Mohamed Hasanin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children 4 to 16 years of age.
• Fasting for elective surgery.

Exclusion Criteria:

• Gastrointestinal problems that may delay gastric emptying.
• Recent abdominal operations.
• Major systemic diseases which could impact gastric emptying.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: supine position; The children will be in the supine position after ingestion of a standard volume of clear fluid.	Other: Supine position; The children will be placed in the supine position after ingestion of a standard volume of clear fluid
Experimental: Semi-sitting position; The children will be in the semi-sitting position after ingestion of a standard volume of clear fluid.	Other: Semi-sitting position; The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children who have complete gastric emptying	Number of children who have complete gastric emptying defined as return of the antral cross-sectional area to the baseline reading	30 minutes after ingestion of clear fluid

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antral cross-sectional area corrected to the body weight	Antral cross-sectional area divided by the body weight	3 hours after ingestion of clear fluid
Hunger satiety score	A score which measures the degree of patient satiety. The score ranges from zero which is the worst value, to five which is the best value.	3 hours after ingestion of clear fluid
Number of children who have complete gastric emptying	Number of children who have complete gastric emptying after 60 minutes, defined as return of the antral cross-sectional area to the baseline reading	60 minutes after ingestion of clear fluid
Number of children who have complete gastric emptying	Number of children who have complete gastric emptying after 120 minutes, defined as return of the antral cross-sectional area to the baseline reading	120 minutes after ingestion of clear fluid

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ashraf Rady, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2018
• Primary Completion (Actual): January 12, 2019
• Study Completion (Actual): January 13, 2019

Study Registration Dates

• First Submitted: November 17, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-92-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No