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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747796
• Other study ID #: N-92-2018
• Status: Completed
• Phase: N/A
• Start date: November 25, 2018
• Est. completion date: January 13, 2019

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 13, 2019
• Est. primary completion date: January 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Fasting

Intervention

Other:
• Supine position
The children will be placed in the supine position after ingestion of a standard volume of clear fluid
• Semi-sitting position
The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid

Locations

Country	Name	City	State
Egypt	Ahmed Mohamed Hasanin	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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