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Completed

NCT Number: NCT03747796

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

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.

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Key information

Conditions

Anesthesia Behavior Fasting Feeding Behavior

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

supine position

Other

The children will be placed in the supine position after ingestion of a standard volume of clear fluid

Semi-sitting position

Other

The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid

Primary outcomes

  1. Number of children who have complete gastric emptying

    Time frame: 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 outcomes

  1. Antral cross-sectional area corrected to the body weight

    Time frame: 3 hours after ingestion of clear fluid

    Antral cross-sectional area divided by the body weight

  2. Hunger satiety score

    Time frame: 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.

  3. Number of children who have complete gastric emptying

    Time frame: 60 minutes after ingestion of clear fluid

    Number of children who have complete gastric emptying after 60 minutes, defined as return of the antral cross-sectional area to the baseline reading

  4. Number of children who have complete gastric emptying

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2018
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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