An observational study in Fasting and Pediatric ALL, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by Boston Children's Hospital · Observational
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.
This study is a prospective observational cohort study which will be conducted in 2 parts including preoperative and intraoperative periods.
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.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 74 observational studies indexed under Fasting.
Browse Fasting studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study will include all patients who aged 0-17 years scheduled for EGD procedure at GPU, Boston Children's Hospital, Longwood.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Actual intragastric content volume (ml)
Actual intragastric content volume (ml) which is suctioned from each pediatric patient is measured
Time frame: 1 day
Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).
Correlation between NPO time(hr) and intraoperative intragastric content volume(ml).
Time frame: 1 day
Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).
Correlation between NPO time(hr) and intraoperative intragastric content acidity (pH).
Time frame: 1 day
Incidence of perioperative hypotension
Hypotension is defined as 20% reduction of normal systolic blood pressure for any age groups
Time frame: 1 day
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.
Time frame: 1 day
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)
Time frame: 1 day
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
Time frame: 1 day
Actual pH of intragastric content
Actual pH of intragastric content which is suctioned from each pediatric patient is measured
Time frame: 1 day
Plan to share: No
Ran from Aug 2018 to primary completion in Dec 2019, 15 months.
Of 46 non-industry observational studies under Fasting, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 48. This study's 15 months is below that.
Counting every sponsor, half of 48 studies reached it within 17 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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