NCT04110613 · Carilion Clinic
RCT: Early Feeding After PEG Placement
(PEG)
What this study is about
randomly assigned controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.
View original scientific description
Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.
Interventions
DIETARY_SUPPLEMENT
noFast: Start tube feeds within 1 hour of procedure
Earliest possible initiation of tube feeding after bedside PEG tube procedure.
Primary outcome measures
Hours fasted
Time frame: 24 hours before to 72 hours after the procedure
Number of hours patients are not receiving prescribed caloric intake
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult subjects over 18 years of age
- Negative pregnancy test for women participants of child-bearing age
- Mechanically ventilated surgical and trauma patients with clinical indication for PEG tube placement
- Tolerating tube feeds at goal prior to procedure
Exclusion criteria
- Patients with aberant gastrointestinal anatomy
- Patients with gastrointestinal motility disorders
- Patients with feeding intolerance prior to PEG tube procedure
- Pregnant women, children, or other vulnerable populations
- Clinical contraindications for PEG tube placement
- PEG performed in setting other than ICU at bedside
Where
- Roanoke, Virginia
Collaborators
Virginia Polytechnic Institute and State University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 26, 2021 · Source of record for eligibility and locations