Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume

August 21, 2023 updated by: Patcharee Sriswasdi, Boston Children's Hospital

Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure

According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake.

This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure.

The investigators believe that the information from this study will help establish a comprehensive NPO guideline.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The ASA and ESA practice guidelines recommend a 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), a 4- hour fasting period for breast milk and a 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. While the ESA guideline suggests 3 ml/kg of clear oral fluids intake as a start point, the ASA does not suggest the allowable amount of ingested fluids/food volume.

According to the current consensus statement from the Association of Paediatric Anaesthetists of Great Britain and Ireland, the European Society of Paediatric Anaesthesiology and L'Association Des Anesthésistes-Réanimateurs Pédiatriques d'Expression Française on clear fluids fasting for elective pediatric general anesthesia in February 2018, this 3 ml/kg volume would mean patients ages 1-5 years old are allowed up to 55 ml, 6-12 years old up to 140 ml and greater than 12 years old up to 250 ml. The European consensus also suggests 1 hour clear fluid fasting for children as a practical way to reduce fasting times without increase aspiration risks.

To prevent preoperative dehydrated states which result in preoperative irritable behavior and intraoperative hypotension, patient fasting states and volume status should be optimized. Schmitz et al showed results of gastric emptying time of less than 30 minutes in healthy 6-14 years old children who had serial MRI scan every 30 minutes up to 120 minutes after drinking 7ml/kg of diluted raspberry syrup in 2011, the published clinical evidence suggested that clear fluids are absorbed to gastric volume of 1 ml/kg after 1 hour without pulmonary aspiration. Gawecka et al. also found no aspiration in ASA I and II children who were assigned to received 10ml/kg of 12.6% oral carbohydrate solution two hours before induction of anesthesia. Those studies showed no pulmonary aspiration event. However; pulmonary aspiration of gastric content is still a mainly concern for anesthesiologists when patients ingested large fluid volume. Previous studies reported incidences of aspiration range from1 to 10:10,000 cases and few cases require intensive care and respiratory support. The liberal clear fluid intake volume has been demonstrated to have similar risk of pulmonary aspiration as fasting patients.

The investigators propose a prospective randomized study on the relationship between assigned amount of clear oral fluid intake (ml/kg) and actual intra-gastric volume and pH of pediatric surgical patients. This study will be done at BCH's Gastroenterology Procedure Unit (GPU). Patients' demographic data will be obtained from charts. Patients will be randomly assigned to drink specific amount of fluid at 2 hours period before scheduled time. Patients or parents will be asked for other type, volume and time of last fluid/food intake. Actual intragastric volume and pH will be measured by the research team from the intragastric content that is removed at the beginning EGD procedures.

The investigators hope to demonstrate the relationship between volume of clear fluid intake at the 2-hour period before induction of anesthesia and actual intragastric volume which provide sufficient evidence of allowable clear fluid intake volume. Finally, the investigators want to use this study information to optimize standard fasting guidelines, to improve patients' preoperative volume status, to increase patient satisfaction and maintain patient safety.

Study Type

Interventional

Enrollment (Estimated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ASA classification: I and II
  • 13-17 years
  • IPD cases or the first OPD case
  • Scheduled for elective EGD procedure.
  • All participants, families or guardians will be fluent in English.

Exclusion Criteria:

  • Emergent EGD procedures
  • Patients with active upper GI bleeding
  • Patients who received preoperative oral medication
  • Patients who are diagnosed as GERD, achalasia or suspected to have gastroparesis status such as uncontrolled diabetes or end stage kidney disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3 ml/kg of clear oral fluid
This group of patient will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Other: Clear oral fluid
clear oral fluid including water, pulp-free juice and tea or coffee without milk.
Active Comparator: 5 ml/kg of clear oral fluid
This group of patient will consume 5 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Other: Clear oral fluid
clear oral fluid including water, pulp-free juice and tea or coffee without milk.
Active Comparator: 7 ml/kg of clear oral fluid
This group of patient will consume 7 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Other: Clear oral fluid
clear oral fluid including water, pulp-free juice and tea or coffee without milk.
Active Comparator: 10 ml/kg of clear oral fluid
This group of patient will consume 10 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time
Other: Clear oral fluid
clear oral fluid including water, pulp-free juice and tea or coffee without milk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric volume
Time Frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Actual gastric content volume (ml) suctioned out of each pediatric patient's stomach
We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric pH
Time Frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Actual gastric acidity (pH) suctioned out of each pediatric patient's stomach
We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Incidence of pulmonary aspiration
Time Frame: We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours
Pulmonary aspiration is defined by the presence of gastric contents in oral cavity or aspiration of gastric content into the larynx. This may cause a syndrome of progressive dyspnea, hypoxia, bronchial wheeze and patchy collapse and consolidation on chest X-ray.
We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Patcharee Sriswasdi, MD, MPH, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-P00029632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We might share IPD if it could maximize patient's benefit.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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