Clinical trial NCT03448991: Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH
Official title: Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Pediatric ALL
Keywords: NPO time
Gastric content
Gastric pH
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 150
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study is a prospective observational cohort study which will be conducted in 2 parts including preoperative and intraoperative periods.

* Preoperative period, patients' demographic information will be collected along with NPO history including times, type ,amount of preoperative fluid/ food intake and patients' anxiety score.
* Intraoperatively, at the beginning of EGD procedure, total volume of intragastric content(ml) and gastric acidity will be measured.

We plan to offer participation to all patients or parents of patients' ages 0-17 years who are scheduled for EGD at GPU, BCH Longwood campus and are fluent in English. A brochure describing our study in English will be given to patients or their families on the day of surgery. If the patient or family agrees to participate in this study, the study will be provided in the GPU theaters.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Actual intragastric content volume (ml)
timeFrame: 1 day
Secondary outcomes:
measure: Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).
timeFrame: 1 day
measure: Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).
timeFrame: 1 day
measure: Incidence of perioperative hypotension
timeFrame: 1 day
measure: Incidence of pulmonary aspiration risk.
timeFrame: 1 day
measure: Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)
timeFrame: 1 day
measure: Incidence of surgery delay or cancellation due to NPO guideline violation
timeFrame: 1 day
measure: Actual pH of intragastric content
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston children hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Patcharee Sriswasdi, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.