← Back to Search

Dietary Supplement

Early Tube Feeding After Gastrostomy Surgery (PEG Trial)

Q: Does the research encompass individuals aged 60 and above?

This research project is open to participants aged 18-100. However, those under the age of 18 and over 65 have more specific clinical trials available with 234 studies for minors and 1083 specifically catered towards senior citizens.

Q: Who fits the criteria to be eligible for enrollment in this trial?

Eligibility to become a participant in this research requires that individuals are between 18 and 100 years of age, have access to mechanical ventilation, and must be among the 1200 recruits sought.

Q: Does this clinical experiment currently have any open opportunities for participation?

Data sourced from clinicaltrials.gov indicates that this research is actively searching for participants, with the initial posting made on September 19th 2019 and the most recent update recorded on October 18th 2021.

Q: What is the cap on enrollment for this research project?

Affirmative, according to the information found on clinicaltrials.gov this medical experiment is actively seeking participants, having been first posted on September 19th 2019 and most recently amended October 18th 2021. The team seeks to recruit 1200 patients from a single site.

N/A

Recruiting

Led By Katie L Bower, MD

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test for women participants of child-bearing age

Tolerating tube feeds at goal prior to procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours before to 72 hours after the procedure

Awards & highlights

PEG Trial Summary

This trial is testing when to start feeding patients through a PEG tube after surgery, to see what works best.

Who is the study for?

This trial is for adults over 18 who are on mechanical ventilation in the ICU due to trauma or surgery and need a PEG tube for feeding. They must have been tolerating tube feeds before the procedure. It's not for those with gut motility issues, feed intolerance, abnormal GI anatomy, or if the PEG isn't placed at an ICU bedside.Check my eligibility

What is being tested?

The study tests whether starting tube feeding within one hour after placing a PEG (feeding) tube is beneficial for ventilated patients in surgical and trauma ICUs. This randomized controlled trial aims to find the best timing for enteral nutrition under these conditions.See study design

What are the potential side effects?

Since this trial involves early feeding through a PEG tube, potential side effects may include abdominal discomfort, bloating, diarrhea, aspiration pneumonia or complications related to the PEG placement like infection.

PEG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant.

Select...

I am managing my tube feeds well before the procedure.

Select...

I am on a ventilator and need a tube placed in my stomach for feeding due to surgery or injury.

PEG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours before to 72 hours after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours before to 72 hours after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours before to 72 hours after the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hours fasted

Secondary outcome measures

Calorie deficit

Complications

PEG Trial Design

2Treatment groups

Active Control

Group I: FAST: Start tube feeds 4 hours after procedureActive Control1 Intervention

The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Group II: noFast: Start tube feeds within 1 hour of procedureActive Control1 Intervention

The noFAST group will have post-PEG tube feeds initiated <1 hour after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carilion ClinicLead Sponsor

71 Previous Clinical Trials

11,506 Total Patients Enrolled

Virginia Polytechnic Institute and State UniversityOTHER

142 Previous Clinical Trials

26,557 Total Patients Enrolled

Katie L Bower, MDPrincipal InvestigatorCarilion Clinic, Virginia Tech Carilion School of Medicine

Media Library

noFAST group (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04110613 — N/A

Malnutrition Research Study Groups: FAST: Start tube feeds 4 hours after procedure, noFast: Start tube feeds within 1 hour of procedure

Malnutrition Clinical Trial 2023: noFAST group Highlights & Side Effects. Trial Name: NCT04110613 — N/A

noFAST group (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04110613 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research encompass individuals aged 60 and above?

"This research project is open to participants aged 18-100. However, those under the age of 18 and over 65 have more specific clinical trials available with 234 studies for minors and 1083 specifically catered towards senior citizens."

Answered by AI

Who fits the criteria to be eligible for enrollment in this trial?

"Eligibility to become a participant in this research requires that individuals are between 18 and 100 years of age, have access to mechanical ventilation, and must be among the 1200 recruits sought."

Answered by AI

Does this clinical experiment currently have any open opportunities for participation?

"Data sourced from clinicaltrials.gov indicates that this research is actively searching for participants, with the initial posting made on September 19th 2019 and the most recent update recorded on October 18th 2021."

Answered by AI

What is the cap on enrollment for this research project?

"Affirmative, according to the information found on clinicaltrials.gov this medical experiment is actively seeking participants, having been first posted on September 19th 2019 and most recently amended October 18th 2021. The team seeks to recruit 1200 patients from a single site."

Answered by AI

Recent research and studies

Journal of the Intensive Care SocietyJournal

Optimising Enteral Nutrition in Critically Ill Patients by Reducing Fasting Times

Segaran, Ella, Ian Barker, and Andrew Hartle. 2016. “Optimising Enteral Nutrition in Critically Ill Patients by Reducing Fasting Times”. Journal of the Intensive Care Society. SAGE Publications. doi:10.1177/1751143715599410.

versusJournal

Earlyversusdelayed Feeding After Placement of a Percutaneous Endoscopic Gastrostomy: A Meta-analysis

Bechtold, Matthew L., Michelle L. Matteson, Abhishek Choudhary, Srinivas R. Puli, Peter P. Jiang, and Praveen K. Roy. 2008. “Earlyversusdelayed Feeding After Placement of a Percutaneous Endoscopic Gastrostomy: A Meta-analysis”. The American Journal of Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1111/j.1572-0241.2008.02108.x.

Scandinavian Journal of GastroenterologyJournal

Complication and Mortality Rate After Percutaneous Endoscopic Gastrostomy Are Low and Indication-dependent*

Schneider, Andrea S., Anika Schettler, Andrea Markowski, Birgit Luettig, Birgit Kaufmann, Sabine Klamt, Henrike Lenzen, et al.. 2014. “Complication and Mortality Rate After Percutaneous Endoscopic Gastrostomy Are Low and Indication-dependent*”. Scandinavian Journal of Gastroenterology. Informa UK Limited. doi:10.3109/00365521.2014.916343.

Acta Anaesthesiologica ScandinavicaJournal