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

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ClinicalTrials.gov Identifier: NCT03741777
Recruitment Status : Not yet recruiting
First Posted : November 15, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Patcharee Sriswasdi, Boston Children’s Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fasting Gastric Emptying Other: Clear oral fluid Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The children included in this study will be randomly assigned into one of four groups by using randomization.org: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume Before Undergoing Elective Esophago-gastro-duodenoscopy (EGD) Procedure
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741777


Contacts
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Contact: Sirirat Rattanaarpa, MD 857-218-8020 sirirat.rattanaarpa@childrens.harvard.edu
Contact: Patcharee Sriswasdi, MD, MPH 617-599-3679 patcharee.sriswasdi@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Patcharee Sriswasdi, MD, MPH Boston Children’s Hospital

Publications:

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Responsible Party: Patcharee Sriswasdi, Attending staff, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03741777     History of Changes
Other Study ID Numbers: IRB-P00029632
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We might share IPD if it could maximize patient's benefit.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patcharee Sriswasdi, Boston Children’s Hospital:
NPO time
Gastric content