Reducing Fasting Time for Breast Milk to 3 Hours

Gastric Residual Volume Clinical Trial

Official title: Reducing Fasting Time for Breast Milk to 3 Hours

Status Recruiting

Clinical Trial Summary

The aim of this study is to ascertain Gastric residual volume (GRV) of gastric contents in 35 infants who are breast fed 3 hours prior to general anaesthesia. The secondary aim of this study is to ascertain how well ultrasound (USS) derived measurement of GRV, using the gastric antrum cross sectional area (ACSA), correlates to direct measurement via aspiration.

Clinical Trial Description

Current UK guidance recommends a fasting time of 4 hours for breast milk prior to general anaesthesia. Gastric emptying (GE) of breast milk and formula preparations has been extensively studied in neonatal intensive care settings for preterm and low birth weight infants, in order to establish optimum feeding regimens for growth. Methodologies utilised in such studies can make applying findings to current routine anaesthetic practice difficult: Such as inclusion of very low birth weight infants, use of fortified breast milk, administering feeds via nasogastric tube and pre-medication of children prior to GA with atropine.

There is a paucity of evidence in breast fed, un-premedicated term babies/infants subjected to a 3 hour fast prior to GA.

Pulmonary aspiration is known to be a rare event associated with lower morbidity and mortality in children than adults . In animal studies, instillation of acidified milk solutions into the lungs of anaesthetised rabbits is associated with increasing severity of lung injury as volume of solution increases above 0.8 ml/kg regardless of pH.

Anaesthetising a child or adult with a full stomach is more hazardous and requires alteration of the anaesthetic technique to minimise risk of aspiration. Gastric ultrasound (USS) is a useful tool for assessing stomach volume prior to induction of anaesthesia. Various formulae have been devised to convert measured gastric antral area to volume in children. USS is validated in older children and adults in measurement of gastric ACSA and derived volume of gastric contents.

We will perform a prospective, interventional study of 35 term infants aged 37 weeks to 18 months, undergoing elective surgery ;

Related Conditions & MeSH terms

• Gastric Residual Volume

• NCT number: NCT05355428
• Study type: Interventional
• Source: King's College Hospital NHS Trust
• Contact: Emily Saffer, Dr
• Phone: 07890549924
• Email: emily.saffer@nhs.net
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Completion date: February 1, 2025