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

155 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment PEG, PEG-J for pneumonia prevention?

Research suggests that PEG feeding can reduce the rate of aspiration pneumonia in stroke patients, and PEG-J may improve outcomes by avoiding gastric passage, which can help prevent pneumonia in patients who cannot tolerate PEG feeding. ^{1 2 3 4 5}

Is the use of feeding tubes like PEG and PEG-J generally safe for humans?

Feeding tubes like PEG and PEG-J are generally considered safe, but they can have risks such as pneumonia, especially in older or chronically ill patients. Proper care and management can help minimize these risks, and PEG-J may offer improved outcomes for those who cannot tolerate PEG. ^{1 6 7 8 9}

How does the PEG-J treatment for pneumonia prevention differ from other treatments?

PEG-J (Percutaneous Endoscopic Transgastric Jejunostomy) is unique because it uses a large-bore tube to bypass the stomach, reducing the risk of aspiration pneumonia by preventing food from entering the lungs. This is different from standard PEG (Percutaneous Endoscopic Gastrostomy) feeding, which can lead to complications like aspiration pneumonia due to gastric passage. ^{1 3 5 10 11}

What is the purpose of this trial?

The goal of this clinical trial is to learn if placing a feeding tube with a small bowel extension (called Percutaneous Endoscopic Gastrostomy With Jejunal Extension \[PEG-J\]) is better at preventing pneumonia than a standard feeding tube (called Percutaneous Endoscopic Gastrostomy \[PEG\]) in people who need long-term tube feeding. Researchers want to know if people who receive a PEG-J have fewer cases of pneumonia in the first 30 days compared to those who receive a standard PEG, and whether PEG-J tubes require more follow-up procedures to fix tube problems. Researchers will compare two different types of feeding tubes: a standard feeding tube that goes into the stomach (PEG) versus a feeding tube that extends past the stomach into the small intestine (PEG-J). This will help determine which type of feeding tube is safer and works better for patients. Participants will be randomly assigned to receive either a PEG or PEG-J feeding tube through a minimally invasive procedure. They will start receiving nutrition through the tube 24 hours after placement and be monitored for 30 days to check for problems like pneumonia or tube malfunction, while receiving regular medical care from their treating doctors. The study is open to people who are 18 years or older and need a new feeding tube for long-term nutrition. People cannot take part if they have pneumonia, COVID-19, an existing feeding tube, previous stomach surgery, gastroparesis (a condition affecting stomach movement), digestive system blockage, are pregnant, or are in prison. All participants must understand English. Participation is voluntary, and participants can leave the study at any time. The study team will carefully monitor all participants for any problems throughout the 30-day period

Research Team

Jerry Dang, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

I do not have pneumonia right now.

Pregnancy

I cannot have an upper endoscopy due to health reasons.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

The Role of Percutaneous Endoscopic Transgastric Jejunostomy in the Management of Enteral Tube Feeding. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of nasojejunal tube feeding for the prevention of pneumonia in adults who are critically ill. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Bronchopulmonary complications associated to enteral nutrition devices in patients admitted to internal medicine departments. [2014]

4. Japan pubmed.ncbi.nlm.nih.gov

Percutaneous Endoscopic Gastrostomy Reduces Aspiration Pneumonia Rate in Stroke Patients with Enteral Feeding in Convalescent Rehabilitation Wards. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Percutaneous endoscopic gastrostomy feeding effects in patients with neurogenic dysphagia and recurrent pneumonia. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Prediction of risk of adverse events related to percutaneous endoscopic gastrostomy: a retrospective study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Improving 30-day mortality after PEG tube placement in England from 2007 to 2019: a retrospective national cohort analysis of 87,862 patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Risk factors for pneumonia after percutaneous endoscopic gastrostomy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Endoscopic Gastrostomy: A Practical Overview on Its Indications, Placement Conditions, Management, and Nursing Care. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Enteral tube feeding and pneumonia. [2011]

11. England pubmed.ncbi.nlm.nih.gov

Percutaneous endoscopic transgastric jejunostomy (PEG-J): a retrospective analysis on its utility in maintaining enteral nutrition after unsuccessful gastric feeding. [2022]