Feeding Tubes for Pneumonia Prevention

Overseen By Melissa V Wills, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jerry Dang

Disqualifiers: Pneumonia, COVID-19, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special type of feeding tube that extends past the stomach into the small intestine (PEG-J) can better prevent pneumonia compared to a standard feeding tube that stops in the stomach (PEG). Researchers aim to determine if individuals with the PEG-J tube experience fewer pneumonia cases and whether these tubes require more repairs in the first 30 days. The trial targets individuals who need long-term tube feeding, do not currently have pneumonia or COVID-19, and have not undergone previous stomach surgery. Participants will randomly receive one of the two types of tubes and be monitored for a month. As an unphased trial, this study allows participants to contribute to important research that could enhance future care for those requiring long-term tube feeding.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these feeding tubes are safe for preventing pneumonia?

Research has shown that both PEG and PEG-J feeding tubes have some safety concerns, but they are generally well-researched. For PEG tubes, about 30% of patients may experience complications such as aspiration pneumonia, a lung infection caused by food or liquid entering the lungs. This is a common serious issue following PEG tube placement.

PEG-J tubes also carry risks but may reduce the chance of aspiration pneumonia compared to PEG tubes. However, some patients still encounter problems. In one study, three individuals died within 30 days of receiving a PEG-J tube, primarily due to aspiration pneumonia and other health issues.

These tubes are intended for individuals with significant health needs, and risks can vary based on individual health conditions. The study aims to learn more about these risks and determine whether one type of tube is safer than the other. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of different feeding tube techniques to prevent pneumonia because these methods aim to improve patient outcomes by minimizing complications. PEG tubes, which deliver nutrition directly to the stomach, are inserted using a safe track technique that ensures precise placement, potentially reducing the risk of aspiration. The PEG-J approach extends this by adding a jejunal extension, which directs nutrients past the stomach into the small intestine, further decreasing the chance of aspiration pneumonia. These techniques offer a more targeted feeding approach compared to traditional methods, which might not provide the same level of precision in preventing pneumonia in at-risk patients.

What evidence suggests that this trial's feeding tubes could be effective for preventing pneumonia?

This trial will compare two types of feeding tubes: the traditional PEG tube and the PEG-J tube. Studies have shown that the traditional PEG tube, which delivers food directly to the stomach, is effective for long-term nutrition. However, about 30% of patients with a PEG tube may develop aspiration pneumonia, where food accidentally enters the lungs. In contrast, PEG-J tubes, which extend into the small intestine, might help lower this risk by bypassing the stomach. Research suggests that while both tubes are safe, PEG-J tubes could potentially reduce cases of pneumonia by avoiding the stomach altogether. This makes PEG-J a promising option for those concerned about pneumonia risk. Participants in this trial will receive either the PEG tube or the PEG-J tube to evaluate their effectiveness in preventing pneumonia. ^{6 7 8 9 10}

Who Is on the Research Team?

Jerry Dang, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults needing a new long-term feeding tube but don't have pneumonia, COVID-19, an existing feeding tube, past stomach surgery, gastroparesis, digestive blockages, aren't pregnant or incarcerated. They must understand English.

Inclusion Criteria

I need a feeding tube as advised by my doctor.

Exclusion Criteria

Pregnancy

I do not have pneumonia right now.

I cannot have an upper endoscopy due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a PEG or PEG-J feeding tube through a minimally invasive procedure. Continuous tube feeds begin 24 hours after placement.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including checking for pneumonia and tube malfunction.

30 days

Regular monitoring throughout the period

What Are the Treatments Tested in This Trial?

Interventions

• PEG
• PEG-J

Trial Overview The study compares two types of feeding tubes: the standard PEG that goes into the stomach and PEG-J which extends into the small intestine. It aims to see if PEG-J reduces pneumonia cases within 30 days without increasing follow-up procedures.

How Is the Trial Designed?

Group I: PEG arm: Patients receiving the 20-French pull-type PEG tube Active Control 1 Intervention

PEG Arm: Participants receive a 20-French pull-type percutaneous endoscopic gastrostomy tube placed into the stomach using standard safe track technique with transillumination and 1:1 finger indentation. The tube is positioned midway between the greater and lesser curves of the stomach. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days.

Group II: PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube Active Control 1 Intervention

Participants receive a 24-French pull-type percutaneous endoscopic gastrostomy tube with a 12-French jejunal extension. After standard PEG placement, the jejunal extension tube is advanced past the pylorus and secured to the small bowel wall with endoclips as indicated. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days.

Who Is Running the Clinical Trial?

Jerry Dang

Lead Sponsor

Trials

1

Recruited

160+

Published Research Related to This Trial

In a study of over 2.7 million hospital discharges, patients with nasogastric (NG) tubes or percutaneous endoscopic gastrostomy (PEG) had a significantly higher risk of bronchial aspiration and aspiration pneumonia, with odds ratios of 9.1 and 15.2 respectively, compared to those without these feeding devices.

Patients using NG tubes or PEG experienced longer hospital stays (averaging 9.2 and 12.7 more days) and higher diagnostic complexity and costs, indicating that while enteral nutrition is effective, it can lead to serious complications that impact overall healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchopulmonary complications associated to enteral nutrition devices in patients admitted to internal medicine departments. Marco, J., Barba, R., Lázaro, M., et al.[2014]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740124001840

Predictors and inpatient outcomes of aspiration pneumonia ... Patients with a PEG tube who develop aspiration pneumonia experience increased mortality rates, extended hospitalizations, a higher frequency of septic shock,

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8387208/

Percutaneous Endoscopic Gastrostomy Reduces ... In this study, we found that aspiration pneumonia was 4.67 times more likely to develop in enteral feeding-dependent stroke patients in the CRWs managed with ...

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

Outcomes of Percutaneous Endoscopic Gastrostomy in ... DISCUSSION. Multiple studies conducted over the last three decades suggest that PEG is a safe and effective means of providing long-term enteral nutrition.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06717321

Study Details | NCT06717321 | Percutaneous Endoscopic ... Current evidence suggests that aspiration pneumonia occurs in up to 30% of patients following PEG placement, with some studies demonstrating aspiration in up to ...

5. giejournal.org giejournal.org/article/S0016-5107(07)00470-1/fulltext

Effective Treatment of Prevalent Pneumonia Reduces in- ... The in-hospital mortality rate dropped form 18% (14 pat.) in the first period to 7% (6 pat.) (P = 0,03). Conclusion: Active pneumonia at the time of PEG ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39276856/

Predictors and inpatient outcomes of aspiration pneumonia ... Patients with a PEG tube who develop aspiration pneumonia experience increased mortality rates, extended hospitalizations, a higher frequency of septic shock,

7. mdpi.com mdpi.com/2227-9032/12/16/1557?

Pre-Stroke Frailty and Outcomes following Percutaneous ... Eleven (37.9%) had died by one year following PEG tube insertion. When dichotomising by frail/non-frail status, eight (27.6%) of the cohort were frail. Clinical ...

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

To PEG or Not To PEG Aspiration pneumonia is the most common cause of death after PEG placement (30). Data consistently show that feeding tubes (both NG and PEG) actually increase.

9. jtd.amegroups.org jtd.amegroups.org/article/view/11276/html

How should this patient with repeated aspiration pneumonia ... Although there is evidence that early PEG placement is associated with increased risk of death, for a subgroup of patients with recurrent aspiration pneumonia ...

10. giejournal.org giejournal.org/article/S0016-5107(02)70282-4/pdf

m2008 aspiration risk as an indication for peg placement ... One-month mortality after percutaneous endoscopic gastrostomy (PEG) placement is high (about 25%) in series of non-selected patients. Several parameters seem ...