Long-term mechanical ventilation and nutrition.
Nicolino Ambrosino, Enrico Clini
https://pubmed.ncbi.nlm.nih.gov/15139570/Actively Recruiting
Led by Carilion Clinic · Updated on 2021-10-26
1200
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the best timing to start feeding after placing a percutaneous endoscopic gastrostomy PEG tube in trauma and surgical intensive care unit ICU patients who are on mechanical ventilation. These patients are at high risk of malnutrition due to interruptions in enteral nutrition caused by procedures or care transitions. The study aims to find evidence that encourages earlier feeding to reduce calorie deficits and improve patient outcomes in this vulnerable group. Participants will be randomly assigned to one of two groups the noFAST group, which starts tube feeding within 1 hour after the PEG procedure, or the FAST group, which begins feeding 4 hours after the procedure. Both groups will receive feeds at the rate and with the formula they tolerated before the procedure. This randomized controlled trial is conducted at the bedside in the ICU setting. During the study, researchers will monitor the number of hours participants fast around the procedure from 24 hours before to 72 hours after, as well as any complications and calorie deficits within 72 hours after the procedure. Participants will receive regular assessments to track their feeding tolerance and nutritional status. The trial is expected to run until September 2026, with ongoing monitoring of outcomes to guide feeding practices after PEG placement in ventilated ICU patients.
CONDITIONS
RCT: Early Feeding After PEG Placement
K
Katie L. Bower, MD
J
Jordan Darden, PhD
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Carilion Clinic
Lead Sponsor
Virginia Polytechnic Institute and State University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Early Tube Feeding (Within 1 Hour) | Delayed Tube Feeding (Begin 4 Hours Post-Procedure) |
|---|---|---|
| What is it? | Initiating tube feeds within one hour after bedside PEG placement in ventilated surgical and trauma patients. | Delaying the start of tube feeds until four hours after bedside PEG placement in ventilated surgical and trauma patients. |
| Role in the trial | Test arm evaluating whether immediate post-PEG feeding improves clinical outcomes and reduces fasting duration. | Comparator arm assessing outcomes in patients who wait four hours before starting tube feeds post-PEG. |
| Primary use | To provide nutritional support quickly after PEG placement, aiming to minimize fasting time, maintain caloric intake, and potentially improve recovery. | To provide nutritional support after a period of fasting following PEG placement, allowing additional time for risk assessment and healing. |
| How is it given or performed? | Tube feeds are started via PEG within one hour of the procedure, following ICU bedside placement, with monitoring for complications. | Tube feeds are initiated four hours post-PEG, allowing a window for observation, with subsequent monitoring for intolerance and complications. |
| Evidence status | Multiple meta-analyses and guideline statements support early feeding post-PEG as safe and effective when no contraindications are present. | Delayed feeding is supported as a safe, conventional alternative when risk factors or intolerance are expected, but evidence suggests no clear added safety benefit over early feeding. |
| Important limitations | Early feeding may not be suitable for patients with abnormal gastrointestinal anatomy, motility disorders, or feeding intolerance, and requires strict monitoring for complications post-PEG placement. | Delaying feeding can prolong fasting, increase calorie deficit, and is not proven to reduce complications compared to early feeding; it may delay nutritional recovery. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo bedside percutaneous endoscopic gastrostomy (PEG) tube placement and begin post-procedure care.
1 procedure visit (in-person)
Duration - Up to 72 hours after the procedure
Participants start tube feeding either within 1 hour or 4 hours after PEG placement, according to their assigned group. Feeding continues at the rate and formula tolerated prior to the procedure.
Regular feeding during hospital stay
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/24773773/Carilion Clinic
Lead Sponsor
Virginia Polytechnic Institute and State University
Collaborating Sponsor