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

NCT06067321 | Unknown

• 1 other identifier: 334555
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fasting; Anesthesia; Pediatric ALL

Keywords

gastric; volume

Outcome Measures

Primary Outcomes (1)

• gastric residual volume

  aspiration of gastric contents via naso-gastric tube

  following induction, pre surgery

Secondary Outcomes (1)

• antral cross sectional area

  pre induction

Study Arms (2)

4 hours formula feed

ACTIVE COMPARATOR

Parents asked to offer formula feed 4 hours prior to anticipated procedure start

Other: abdominal ultrasound, insertion of naso-gastric tube

6 hour formula feed

ACTIVE COMPARATOR

Parents asked to offer formula 6 hours prior to anticipated procedure start

Other: abdominal ultrasound, insertion of naso-gastric tube

Interventions

abdominal ultrasound, insertion of naso-gastric tube OTHER

measurement antral cross sectional area, volume and pH of residual stomach contents

4 hours formula feed; 6 hour formula feed

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term or term corrected (\> 37 weeks) upto 12 months Formula fed ASA 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Emily Saffer

London, Greater London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Fasting; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

emily saffer

CONTACT

07890549924; emily.saffer@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 4, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)