Clinical trial NCT03747796: The Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound
Official title: Evaluation of the Impact of Semi-sitting Position Versus Supine Position on Gastric Emptying in Children Using Gastric Ultrasound: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Fasting
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of children who have complete gastric emptying
timeFrame: 30 minutes after ingestion of clear fluid
Secondary outcomes:
measure: Antral cross-sectional area corrected to the body weight
timeFrame: 3 hours after ingestion of clear fluid
measure: Hunger satiety score
timeFrame: 3 hours after ingestion of clear fluid
measure: Number of children who have complete gastric emptying
timeFrame: 60 minutes after ingestion of clear fluid
measure: Number of children who have complete gastric emptying
timeFrame: 120 minutes after ingestion of clear fluid
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
affiliation: Cairo University
name: Ashraf Rady, Professor
role: STUDY_DIRECTOR
References: