Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH

NCT03448991 | Completed

• 1 other identifier: IRB-P00027981
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

According to normal physiology, the longer fasting period allows food particles to pass stomach through small intestines to minimize intragastric content. The practice guidelines recommend 2-hour fasting period for clear fluid (including water, pulp-free juice and tea or coffee without milk), 4- hour fasting period for breast milk and 6-hour fasting period for non-human milk and solid food to reduce risks of pulmonary aspiration. As a result of longer fasting period, patients tend to experience preoperative dehydrated states and intraoperative hypotension. Patients' demographic data will be obtained from charts. Parents will be asked for type, volume of fluid/food intake and NPO time. This study will be done at BCH's Gastroenterology Procedure Unit (GPU) theaters to measure actual intragastric volume and pH at the beginning esopagogastroduodenoscopy procedures. We hope to demonstrate the relationship between NPO time and actual intragastric volume which provide sufficient data of NPO time to ensure patient's safety.

Conditions

Fasting; Pediatric ALL

Keywords

NPO time; Gastric content; Gastric pH

Outcome Measures

Primary Outcomes (1)

• Actual intragastric content volume (ml)

  Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured

  1 day

Secondary Outcomes (7)

• Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).

  1 day

• Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).

  1 day

• Incidence of perioperative hypotension

  1 day

• Incidence of pulmonary aspiration risk.

  1 day

• Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)

  1 day

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all patients who aged 0-17 years scheduled for EGD procedure at GPU, Boston Children's Hospital, Longwood.

You may qualify if:

• \- All patients who aged 0-17 years scheduled for EGD procedure.

You may not qualify if:

• \- Patients who required emergency EGD procedures and patients with active upper GI bleeding.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston children hospital

Boston, Massachusetts, 02115, United States

Location

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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Song IK, Kim HJ, Lee JH, Kim EH, Kim JT, Kim HS. Ultrasound assessment of gastric volume in children after drinking carbohydrate-containing fluids. Br J Anaesth. 2016 Apr;116(4):513-7. doi: 10.1093/bja/aew031.

  PMID: 26994229 RESULT

• 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 RESULT

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

Study Officials

• Patcharee Sriswasdi, MD.

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 28, 2018
• Study Start: August 24, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)