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Completed

NCT Number: NCT03448991

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

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.

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Key information

Conditions

Fasting Behavior Feeding Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston children hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Actual intragastric content volume (ml)

    Time frame: 1 day

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

Secondary outcomes

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

    Time frame: 1 day

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

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

    Time frame: 1 day

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

  3. Incidence of perioperative hypotension

    Time frame: 1 day

    Hypotension is defined as 20% reduction of normal systolic blood pressure for any age groups

  4. Incidence of pulmonary aspiration risk.

    Time frame: 1 day

    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.

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

    Time frame: 1 day

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

  6. Incidence of surgery delay or cancellation due to NPO guideline violation

    Time frame: 1 day

    Surgery delay is defined when the patient's queue is postponed in order to wait for proper NPO time

  7. Actual pH of intragastric content

    Time frame: 1 day

    Actual pH of intragastric content which is suctioned from each pediatric patient is measured

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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