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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448991
• Other study ID #: IRB-P00027981
• Status: Completed
• Start date: August 24, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: January 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasting
• Pediatric ALL

Locations

Country	Name	City	State
United States	Boston children hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Andersson H, Zarén 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. — View Citation

Dennhardt N, Beck C, Huber D, Sander B, Boehne M, Boethig D, Leffler A, Sümpelmann R. Optimized preoperative fasting times decrease ketone body concentration and stabilize mean arterial blood pressure during induction of anesthesia in children younger tha — View 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. — View Citation

Phillips S, Daborn AK, Hatch DJ. Preoperative fasting for paediatric anaesthesia. Br J Anaesth. 1994 Oct;73(4):529-36. Review. — View 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 Tas — View 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. d — View Citation

Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actual intragastric content volume (ml)	Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured	1 day
Secondary	Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).	Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).	1 day
Secondary	Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).	Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).	1 day
Secondary	Incidence of perioperative hypotension	Hypotension is defined as 20% reduction of normal systolic blood pressure for any age groups	1 day
Secondary	Incidence of pulmonary aspiration risk.	Pulmonary aspiration is defined by the regurgitation of gastric contents into the larynx and the respiratory tract and cause a syndrome of progressive dyspnea, hypoxia, bronchial wheeze and patchy collapse, consolidation on chest X-ray or all.	1 day
Secondary	Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)	Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)	1 day
Secondary	Incidence of surgery delay or cancellation due to NPO guideline violation	Surgery delay is defined when the patient's queue is postponed in order to wait for proper NPO time	1 day
Secondary	Actual pH of intragastric content	Actual pH of intragastric content which is suctioned from each pediatric patient is measured	1 day