An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using Beside Gastric Ultrasound

An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using

The aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. The primary hypothesis is that 'Sip Til Send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.

Study Overview

• Status: Completed
• Conditions: Aspiration; Gastric Contents, Anesthesia
• Intervention / Treatment: Other: liberal hydration

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

• Study Contact: Name: Ryan Howle; Phone Number: 35314085200; Email: rhowle@coombe.ie
• Study Contact Backup: Name: Colleen Harnett; Phone Number: 35314085200; Email: charnett@coombe.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Coombe Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

women who are undergoing a planned elective caesarean delivery

Description

Inclusion Criteria:

• planned caesarean delivery under regional anaesthesia
• adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids

Exclusion Criteria:

• age less than 18
• inability to understand English

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gastric volume	whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section.	3 months

Collaborators and Investigators

• Sponsor: Coombe Women and Infants University Hospital
• Investigators: Principal Investigator: Ryan Howle, Coombe Womens Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: GUS123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No