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Clear Liquid Diet for Reducing Pulmonary Aspiration Risk
N/A
Waitlist Available
Led By Sudipta Sen, MD, FASA
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients taking Glucagon Like Peptide-1 Receptor (GLP-1 RA) agonists
Undergoing upper endoscopy only - no colonoscopy due to prep
Must not have
Large hiatal hernia
Previous fundoplication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to procedure ( within 2 hours before procedure)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if fasting before a medical procedure and switching to a specific diet can help reduce the risk of certain complications in patients taking certain medications. The study will also look at how fasting affects
Who is the study for?
This trial is for patients on GLP-1 receptor agonists who are scheduled for upper endoscopy. They're looking at whether a clear liquid diet (CLD) for 24 hours before the procedure can help reduce stomach contents and improve safety during anesthesia.
What is being tested?
The study tests if a clear liquid diet versus standard fasting protocols can lower residual gastric content in patients taking GLP-1 RA medications before receiving anesthesia. It also examines patient comfort, timing of gastric emptying, choice of anesthesia, and any adverse events.
What are the potential side effects?
Potential side effects may include increased thirst, hunger, anxiety due to prolonged fasting; nausea, vomiting, retching; abdominal bloating or pain; and variations in the effectiveness of preoperative measures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking GLP-1 receptor agonists.
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I am scheduled for an upper endoscopy without a colonoscopy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a large hiatal hernia.
Select...
I have had surgery to treat acid reflux.
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I have had surgery to remove or bypass part of my stomach.
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I cannot turn to lie on my right side.
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I am currently taking erythromycin, metoclopramide, domperidone, or opioids.
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I have a history of delayed stomach emptying.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to procedure ( within 2 hours before procedure)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to procedure ( within 2 hours before procedure)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants that show prevalence of increased RGC determined using preoperative GUS
Secondary study objectives
Number of participants that show anxiety as assessed by the VAS
Number of participants that show hunger as assessed by the VAS
Number of participants that show thirst as assessed by the VAS
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged fastingExperimental Treatment1 Intervention
Group II: Standard nil per os (NPO)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,933 Total Patients Enrolled
1 Trials studying Pulmonary Aspiration
132 Patients Enrolled for Pulmonary Aspiration
Sudipta Sen, MD, FASAPrincipal InvestigatorThe University of Texas Health Science Center, Houston