Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia

Anesthesia Clinical Trial

Official title:

Comparison of Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia: A Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06067321
• Other study ID #: 334555
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: September 2023
• Source: King's College Hospital NHS Trust
• Contact: emily saffer
• Phone: 07890549924
• Email: emily.saffer[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The safety implications of prolonged fasting in young children prior to general anaesthesia are well described. Current UK guidance recommends a fasting time of 6 hours for formula milk prior to general anaesthesia. European guidance published in 2022 recommended a reduced fast of 4 hours for infants taking formula milk, albeit with a downgraded level 2B of evidence given the paucity of high quality research in this area. Although pulmonary aspiration of gastric contents under anaesthesia in children is a rare event, animal studies suggest that aspiration of particulate matter at volumes greater than 0.8 ml/kg gastric volume are associated with demonstrable lung injury and mortality. Although rate of gastric emptying of formula preparations has been extensively studied in neonatal intensive care settings for preterm babies using ultrasound, few studies have measured gastric volume directly in healthy term infants undergoing anaesthesia.

Description:

Traditional fasting guidelines of 6 hours for formula milk may be unnecessarily long. In practice, children also tend to be fasted for longer than the guidelines advise, as they may not always feed on cue, and delays in the hospital can occur on the day of surgery. Prolonged fasting in young children and infants is less well tolerated than in adults and can lead to hunger, dehydration and low blood sugar, as well as distress for the child and parents. We know from previous research in smaller babies that after a formula feed, the stomach empties by half in around 80 minutes, and empties completely by around 3 hours. The investigators want to find out if young children and infants who are fed with formula milk 4 hours prior to an anaesthetic have similar levels of stomach contents at the time of their anaesthetic as those who are fed at 6 hours. The investigators will carry out a clinical trial where children are randomised into 2 groups. Parents of children in Group 1 will be asked to offer a formula feed to their child 6 hours prior to the planned start time of their anaesthetic. Parents of children in Group 2 will be asked to offer a formula feed to their child 4 hours prior to the planned start time of their anaesthetic. Prior to having their anaesthetic a study team member will perform an abdominal ultrasound scan to check and record antral cross sectional area. Once asleep, gastric aspiration will be performed via naso-gastric tube. Volume, colour and pH of the fluid will be measure The volume and acidity of any stomach contents will be compared between group 1 and group 2.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

Term or term corrected (> 37 weeks) upto 12 months Formula fed ASA 1-3 Exclusion Criteria: Significant reflux Co-administration of drugs known to impact gastric motility or PH of gastric contents Significant respiratory comorbidity including chronic lung disease on home oxygen Significant cardiac comorbidity

Related Conditions & MeSH terms

• Anesthesia
• Fasting
• Pediatric ALL

Intervention

Other:
• abdominal ultrasound, insertion of naso-gastric tube
measurement antral cross sectional area, volume and pH of residual stomach contents

Locations

Country	Name	City	State
United Kingdom	Emily Saffer	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric residual volume	aspiration of gastric contents via naso-gastric tube	following induction, pre surgery
Secondary	antral cross sectional area	ultrasound of abdomen	pre induction