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

Not Applicable

Completed

• Conditions: Anesthesia; Fasting
• Interventions: Other: Supine position; Other: Semi-sitting position

• Registration Number: NCT03747796
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-11-17
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Study Start: 2018-11-25
• Status Verified: 2019-01
• Primary Completion: 2019-01-12
• Study Completion: 2019-01-13
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine position	Supine position	The children will be in the supine position after ingestion of a standard volume of clear fluid.
Semi-sitting position	Semi-sitting position	The children will be in the semi-sitting position after ingestion of a standard volume of clear fluid.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antral cross-sectional area corrected to the body weight	3 hours after ingestion of clear fluid	Antral cross-sectional area divided by the body weight
Hunger satiety score	3 hours after ingestion of clear fluid	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.
Number of children who have complete gastric emptying	120 minutes after ingestion of clear fluid	Number of children who have complete gastric emptying after 120 minutes, defined as return of the antral cross-sectional area to the baseline reading

Trial Locations

Locations (1)

Ahmed Mohamed Hasanin; 🇪🇬 Cairo, Egypt