Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID04110613

A Randomized Controlled Trial to Reduce Periprocedural Fasting in Ventilated Trauma and Surgical Intensive Care Patients

Led by Carilion Clinic · Updated on 2021-10-26

1200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Carilion Clinic

Lead Sponsor

V

Virginia Polytechnic Institute and State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

RCT: Early Feeding After PEG Placement

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients with aberrant 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of procedure

Participants undergo bedside percutaneous endoscopic gastrostomy (PEG) tube placement and begin post-procedure care.

1 procedure visit (in-person)

Treatment

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

Trial Site Locations

Total: 1 location

1

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States, 24014

Actively Recruiting

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Research Team

K

Katie L. Bower, MD

J

Jordan Darden, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.).

Stephen A McClave, Robert G Martindale, Vincent W Vanek...

https://pubmed.ncbi.nlm.nih.gov/19398613

Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients.

Miroslav P Peev, D Dante Yeh, Sadeq A Quraishi...

https://pubmed.ncbi.nlm.nih.gov/24714361

A randomized prospective trial of immediate vs. next-day feeding after percutaneous endoscopic gastrostomy in intensive care patients.

Jurgen Stein, Arnd Schulte-Bockholt, Marion Sabin...

https://pubmed.ncbi.nlm.nih.gov/12415457

Endoscopic management of enteral tubes in adult patients - Part 2: Peri- and post-procedural management. European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

Paraskevas Gkolfakis, Marianna Arvanitakis, Edward J Despott...

https://pubmed.ncbi.nlm.nih.gov/33348410

Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis.

Matthew L Bechtold, Michelle L Matteson, Abhishek Choudhary...

https://pubmed.ncbi.nlm.nih.gov/18721239