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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03448991
Enrollment
150
Registered
2018-02-28
Start date
2018-08-24
Completion date
2019-12-11
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Pediatric ALL

Keywords

NPO time, Gastric content, Gastric pH

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.

Interventions

None listed

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Actual intragastric content volume (ml)1 dayActual intragastric content volume (ml) which is suctioned from each pediatric patient is measured

Secondary

MeasureTime frameDescription
Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).1 dayCorrelation between NPO time(hr) and intraoperative intragastric content acidity (pH).
Incidence of perioperative hypotension1 dayHypotension is defined as 20% reduction of normal systolic blood pressure for any age groups
Incidence of pulmonary aspiration risk.1 dayPulmonary 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.
Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).1 dayCorrelation between NPO time(hr) and intraoperative intragastric content volume(ml).
Incidence of surgery delay or cancellation due to NPO guideline violation1 daySurgery delay is defined when the patient's queue is postponed in order to wait for proper NPO time
Actual pH of intragastric content1 dayActual pH of intragastric content which is suctioned from each pediatric patient is measured
Correlation between preoperative patient's anxiety score and actual intragastric content volume (ml)1 dayCorrelation between preoperative patient's anxiety score and actual intragastric content volume (ml)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026