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NCT03741777 · ClinicalTrials.gov registry record · NA
Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume
A NA study of Fasting and Gastric Emptying, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 288
- Enrollment target
- 1
- Study location
NCT03741777 is a NA study of Fasting and Gastric Emptying that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 288 participants, above the 174-participant average among 8 other Fasting trials with a reported enrollment target (66% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03741777, a NA study of Fasting and Gastric Emptying, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 288 participants
- Enrollment target
- 1
- Study location
Study Summary
According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake. This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure. The investigators believe that the information from this study will help establish a comprehensive NPO guideline.
Conditions Studied
Interventions
- OTHER Clear oral fluid
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2024-02-29 |
| Est. Completion | 2025-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03741777
The ClinicalTrials.gov registry entry for NCT03741777 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 174-participant average among 8 other Fasting trials with a reported enrollment target (66% higher). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Fasting appearing as the primary indexed condition, and to 1 intervention - of which Clear oral fluid is the first listed.
NCT03741777 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03741777 about?
NCT03741777 is a clinical study titled "Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume". According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for pro...
What is the current status of trial NCT03741777?
This trial is currently recruiting. It is a NA study. The enrollment target is 288 participants. The study started on 2024-02-29. Estimated completion is 2025-12.
What conditions does trial NCT03741777 study?
This clinical trial studies the following conditions: Fasting, Gastric Emptying.
What interventions are being tested in trial NCT03741777?
The interventions under investigation include: Clear oral fluid (OTHER).
Who is sponsoring clinical trial NCT03741777?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03741777 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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