Clear Liquid Diet for Reducing Pulmonary Aspiration Risk
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a clear liquid diet (CLD) before an upper endoscopy can reduce the risk of pulmonary aspiration (when stomach contents enter the lungs) in patients taking GLP-1 RA medications, commonly used for diabetes management. It will also assess the diet's effects on thirst, hunger, and anxiety levels. Participants will be divided into two groups: one will follow prolonged fasting with a clear liquid diet, and the other will adhere to standard fasting instructions. Suitable candidates for this trial are individuals currently taking GLP-1 RA medications who will undergo an upper endoscopy and have not had major stomach surgeries. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance medical guidelines and patient safety.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking erythromycin, metoclopramide, domperidone, or opioids.
What prior data suggests that this protocol is safe for patients on GLP-1 RAs?
Research has shown that GLP-1 receptor agonists (GLP-1 RAs), medications often used for diabetes, do not significantly increase the risk of pneumonia from inhaling food or liquid shortly after surgery. People taking these medications before surgery did not face a higher chance of this type of pneumonia.
However, warnings exist about the potential risk of inhaling substances into the lungs during general anesthesia or deep sedation. These findings are based on individuals who had surgery and used GLP-1 RAs beforehand. While some risk is present, studies do not indicate a clear increase in pneumonia risk immediately after surgery.
Overall, GLP-1 RAs are generally considered safe, but awareness of these potential risks is important, especially for those planning surgery.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how a clear liquid diet might reduce the risk of pulmonary aspiration for patients using GLP-1 receptor agonists (GLP-1 RAs). Unlike the traditional NPO (nothing by mouth) instructions before procedures, this method could allow patients to consume certain liquids without increasing aspiration risk. This approach could improve comfort and compliance for patients who typically face prolonged fasting, potentially making medical procedures less stressful and more manageable.
What evidence suggests that this trial's treatments could be effective for reducing pulmonary aspiration risk?
Research shows that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can cause more leftover food in the stomach, posing a risk before procedures like endoscopy. Studies have found that people taking GLP-1 RAs are more likely to experience this, increasing the risk of complications such as aspiration, where food or liquid accidentally enters the lungs. This trial will compare two groups of GLP-1 RA users: one group will follow prolonged fasting instructions, while the other will follow standard NPO instructions. However, GLP-1 RAs have not been significantly linked to causing pneumonia after surgery. These medications slow stomach emptying, making fasting important for patients using them.12678
Who Is on the Research Team?
Sudipta Sen, MD, FASA
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-procedure Preparation
Participants undergo prolonged fasting from solids and transition to a clear liquid diet for 24 hours to decrease residual gastric content
Procedure and Assessment
Participants undergo upper endoscopy and preoperative gastric ultrasound assessment to evaluate residual gastric content and determine anesthesia choice
Follow-up
Participants are monitored for adverse events and symptoms such as nausea, vomiting, and abdominal pain post-procedure
What Are the Treatments Tested in This Trial?
Interventions
- GLP-1 RA
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Published Research Related to This Trial
Citations
Postoperative Aspiration Pneumonia Among Adults Using ...
This cohort study found no significant association between the preoperative use of GLP-1 RAs and short-term postoperative aspiration pneumonia.
Postoperative Aspiration Pneumonia Among Adults Using ...
This cohort study investigates whether use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) is associated with postoperative aspiration pneumonia.
3.
associationofanaesthetists-publications.onlinelibrary.wiley.com
associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.16601Association between glucagon‐like peptide‐1 receptor ...
Patients using glucagon-like peptide-1 receptor agonists are at increased risk of presenting for anaesthesia with residual gastric contents, ...
Glucagon-like peptide-1 receptor agonists increase the risk ...
GLP1-RA use increased the risk of RGC, pulmonary aspiration, interrupted and repeated endoscopy and gastric transit time, reducing the safety and completion of ...
Glucagon-like peptide-1 receptor agonists before upper ...
GLP-1 receptor agonists were associated with a higher risk of discontinuation of endoscopy, possibly owing to a higher risk of retained gastric content.
GLP-1 and dual GIP/GLP-1 receptor agonists: potential risk ...
Healthcare professionals should be aware of the potential risk of pulmonary aspiration in patients using GLP-1 or dual GIP/GLP-1 receptor ...
Glucagon-Like Peptide-1 Receptor Agonists and Peri ...
The initial ASA guidance did not cite studies showing an increased risk of aspiration/pneumonia in patients on GLP-1RAs undergoing elective ...
8.
pharmaceutical-journal.com
pharmaceutical-journal.com/article/news/mhra-warns-of-pulmonary-aspiration-risk-for-glp-1-receptor-agonists-during-general-anaesthesia-or-deep-sedationMHRA warns of pulmonary aspiration risk for GLP-1 ...
A review has found that all available data support a risk of pulmonary aspiration from glucagon-like peptide-1 or dual glucose-dependent insulinotropic ...
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