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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03448991
Collaborator
(none)
150
1
15.6
9.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of NPO Time and Type of Food Intake on Preoperative Residual Gastric Content and pH
    Actual Study Start Date :
    Aug 24, 2018
    Actual Primary Completion Date :
    Dec 11, 2019
    Actual Study Completion Date :
    Dec 11, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Actual intragastric content volume (ml) [1 day]

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

    Secondary Outcome Measures

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

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

    3. Incidence of perioperative hypotension [1 day]

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

    4. Incidence of pulmonary aspiration risk. [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) [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 [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 [1 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston children hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Patcharee Sriswasdi, MD., Boston Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patcharee Sriswasdi, Principal investigator, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT03448991
    Other Study ID Numbers:
    • IRB-P00027981
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Jan 19, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Patcharee Sriswasdi, Principal investigator, Boston Children's Hospital

    Study Results

    No Results Posted as of Jan 19, 2021