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

NCT03741777 | Recruiting DMC

• 1 other identifier: IRB-P00029632
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting; Gastric Emptying

Keywords

NPO time; Gastric content

Outcome Measures

Primary Outcomes (1)

• Gastric volume

  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 Outcomes (2)

• Gastric pH

  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

  We will collect data on a day of surgery from patient's arrival until they are discharged from PACU upto 24 hours

Study Arms (4)

3 ml/kg of clear oral fluid

ACTIVE COMPARATOR

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

5 ml/kg of clear oral fluid

ACTIVE COMPARATOR

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

7 ml/kg of clear oral fluid

ACTIVE COMPARATOR

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

10 ml/kg of clear oral fluid

ACTIVE COMPARATOR

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

Interventions

Clear oral fluid OTHER

clear oral fluid including water, pulp-free juice and tea or coffee without milk.

10 ml/kg of clear oral fluid; 3 ml/kg of clear oral fluid; 5 ml/kg of clear oral fluid; 7 ml/kg of clear oral fluid

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 01225, United States

RECRUITING

Related Publications (8)

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 BACKGROUND

• Maltby JR, Sutherland AD, Sale JP, Shaffer EA. Preoperative oral fluids: is a five-hour fast justified prior to elective surgery? Anesth Analg. 1986 Nov;65(11):1112-6.

  PMID: 3767008 BACKGROUND

• Andersson H, Zaren B, Frykholm P. Low incidence of pulmonary aspiration in children allowed intake of clear fluids until called to the operating suite. Paediatr Anaesth. 2015 Aug;25(8):770-777. doi: 10.1111/pan.12667. Epub 2015 May 4.

  PMID: 25940831 BACKGROUND

• Phillips S, Daborn AK, Hatch DJ. Preoperative fasting for paediatric anaesthesia. Br J Anaesth. 1994 Oct;73(4):529-36. doi: 10.1093/bja/73.4.529.

  PMID: 7999497 BACKGROUND

• Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sumpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger than 36 months: a prospective observational cohort study. Paediatr Anaesth. 2016 Aug;26(8):838-43. doi: 10.1111/pan.12943. Epub 2016 Jun 13.

  PMID: 27291355 BACKGROUND

• Schmitz A, Kellenberger CJ, Liamlahi R, Studhalter M, Weiss M. Gastric emptying after overnight fasting and clear fluid intake: a prospective investigation using serial magnetic resonance imaging in healthy children. Br J Anaesth. 2011 Sep;107(3):425-9. doi: 10.1093/bja/aer167. Epub 2011 Jun 14.

  PMID: 21676893 BACKGROUND

• Gawecka A, Mierzewska-Schmidt M. Tolerance of, and metabolic effects of, preoperative oral carbohydrate administration in children - a preliminary report. Anaesthesiol Intensive Ther. 2014 Apr-Jun;46(2):61-4. doi: 10.5603/AIT.2014.0013.

  PMID: 24858963 BACKGROUND

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Patcharee Sriswasdi, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sirirat Rattanaarpa, MD

CONTACT

857-218-8020; sirirat.rattanaarpa@childrens.harvard.edu

Patcharee Sriswasdi, MD, MPH

CONTACT

617-599-3679; patcharee.sriswasdi@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending staff

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: November 15, 2018
• Study Start: February 29, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)