Timing of Stopping Tube Feeding Before Surgery

Overseen By Antoinette Burger, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jeffrey Coughenour

Disqualifiers: Gastric obstruction, Bowel obstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for stopping tube feeding before surgery to improve surgical outcomes. Researchers are examining whether pausing nutritional support is necessary and, if so, when it should occur for patients receiving nutrition through a tube. The study includes two groups: those receiving naso-enteral feeding (a tube through the nose to the stomach) before PEG placement (a feeding tube inserted into the stomach), and those with a PEG tube before tracheostomy (a tube in the windpipe) placement. This trial may suit individuals already using a feeding tube and scheduled for these specific surgeries. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance surgical outcomes for tube-fed patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on the timing of stopping tube feeding before surgery.

What prior data suggests that this protocol is safe for patients undergoing surgical procedures?

Research has shown that starting with naso-enteral feeding before using a PEG tube (a tube placed in the stomach for feeding) is generally safe. This method might reduce infection risk compared to other feeding options. Most patients tolerate it well, experiencing fewer issues like infections or tube complications.

For those using PEG feeding before undergoing a tracheostomy (a procedure to assist with breathing), it is also considered safe. PEG tubes are widely used and have a strong safety record, providing essential nutrition for individuals unable to eat by mouth. While minor issues like tube blockage or mild irritation might occur, they are uncommon.

Both feeding methods have been studied extensively and are regularly used in medical care, indicating a strong safety record for patients considering participation in a clinical trial involving these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the timing of stopping tube feeding before surgery, which could optimize patient outcomes. Unlike current practices, which often follow rigid guidelines, this trial examines the effects of varying the timing of interrupting enteral nutrition. By doing so, it aims to balance the benefits of nutrition with the safety concerns of surgery, potentially leading to more personalized and effective nutritional management for patients undergoing procedures like PEG or tracheostomy placement. This could result in improved recovery times and reduced complications, making it a significant advancement in surgical care.

What evidence suggests that this trial's protocol for timing of stopping tube feeding before surgery could be effective?

This trial will compare different timings for stopping tube feeding before surgery. Research has shown that feeding through a tube in the nose, known as naso-enteral feeding, is safe and effective before certain procedures like PEG placement (a type of feeding tube). Studies indicate that stopping this feeding before surgery doesn't offer extra benefits and might not be necessary. Specifically, for PEG nutrition before a tracheostomy (a procedure to assist with breathing), starting feeds early, even within four hours after a PEG procedure, is safe and doesn't increase complications. Guidelines suggest that feeding can safely begin soon after a gastrostomy (another type of feeding tube) without delay. These findings suggest that adjusting the timing of feeding might not harm patients and could help maintain stable nutrition levels. Participants in this trial will be in one of two groups: those receiving naso-enteral feeding scheduled for PEG placement, and those receiving PEG nutrition scheduled for tracheostomy placement. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey Coughenour, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for patients who receive tube feeding due to gastrostomy or need tracheostomy care and are scheduled for a surgical procedure. The study excludes those with specific dietary requirements, allergies to the feeding formula, or conditions that might interfere with the trial outcomes.

Inclusion Criteria

I need or have a tracheostomy or a feeding tube.

I am over 18 years old.

Exclusion Criteria

Patients unable to receive enteral nutrition

Patients who are pregnant and/or breastfeeding

I have a blockage in my stomach or intestines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgical Nutrition Management

Participants' enteral nutrition is managed and potentially stopped at different time points prior to surgical procedures

0-8 hours

Surgical Procedure

Participants undergo tracheostomy and/or PEG placement

1 day

Follow-up

Participants are monitored for safety and effectiveness after the surgical procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• No DIET Trial: Dogmatic Interruption of Enteral nuTrition

Trial Overview The No DIET Trial investigates when to stop tube feeding before surgery. It compares several approaches: not stopping nutrition until reaching the OR, halting it when called to OR, or ceasing it 4, 6, or 8 hours beforehand.

How Is the Trial Designed?

Group I: Patients receiving naso-enteral feeding, scheduled for PEG placement. Experimental Treatment 2 Interventions

Group II: Patients receiving PEG nutrition, scheduled for tracheostomy placement. Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Jeffrey Coughenour

Lead Sponsor

Trials

1

Recruited

120+

Published Research Related to This Trial

A service improvement project in a London ICU showed that implementing a fasting guideline significantly reduced interruptions to enteral nutrition delivery, particularly during airway procedures.

The guideline not only decreased fasting times but also led to a notable reduction in calorie deficits for critically ill patients, improving their overall nutrition delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising enteral nutrition in critically ill patients by reducing fasting times. Segaran, E., Barker, I., Hartle, A.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5409712/

The Effects of Pre-Operative Enteral Nutrition from Nasal ... Two weeks of pre-operative strengthening EN treatment is safe and effective for post-operative gastric outlet obstruction patients, and has ...

2. withpower.com withpower.com/trial/phase-gastrostomy-5-2024-70ff4

Timing of Stopping Tube Feeding Before Surgery Research suggests that stopping tube feeding before surgery is generally safe, as fasting does not provide benefits after gastrointestinal surgery and does not ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28394302/

The Effects of Pre-Operative Enteral Nutrition from Nasal ... Pre-EN through a nasal-jejunum feeding tube and placed under a gastroscope in GOO patients was safe, feasible, and beneficial to the nutrition status, immune ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06431048

No DIET Trial: Dogmatic Interruption of Enteral nuTrition Naso-enteral nutrition will be stopped 2 hours before the scheduled procedure (tracheostomy + PEG or PEG only).

5. sciencedirect.com sciencedirect.com/science/article/pii/S266726852500035X

Interruptions in administration of enteral feeding and ... According to Reid [15], feeding was stopped between 6 to 24 hours before tracheostomy and decreased 8 % of the feeding days. Another group found that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3975672/

Outcomes of Percutaneous Endoscopic Gastrostomy in ... The majority of patients (51%) received nutrition via a nasogastric (NG) tube prior to PEG tube placement, while 33% and 14% were fed via parenteral nutrition ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480422000257

When Is It Safe to Feed After Surgical Feeding Tube ... PEG tube placement in trauma patients has demonstrated a significantly lower complication rate than surgically placed tubes.3. After the surgical procedure to ...

8. giejournal.org giejournal.org/article/S0016-5107(24)03505-3/fulltext

American Society for Gastrointestinal Endoscopy guideline ... Outcomes of interest included all-cause mortality at 30 days, malfunction of feeding tube, colon perforation, peritonitis, technical failure, ...

9. jtd.amegroups.org jtd.amegroups.org/article/view/40228/html

An overview of percutaneous endoscopic gastrostomy tube ... It did however find that enteral nutrition may be associated with lower risk of sepsis as compared to parenteral nutrition (RR 0.59, 95% CI, 0.37–0.95) (11).

10. med.virginia.edu med.virginia.edu/ginutrition/wp-content/uploads/sites/199/2015/11/PlonkArticle-july2005.pdf

To PEG or Not To PEG PEG tubes quickly became the procedure of choice for providing enteral nutrition in the United States. In. Medicare patients, its use doubled from about 61,000.