RCT: Early Feeding After PEG Placement (PEG)

October 18, 2021 updated by: Katie Love Bower, Carilion Clinic

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

Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Trauma and surgical intensive care unit(TSICU) patients supported with mechanical ventilation are at high risk for complications associated with malnutrition (Ambrosino and Clini 2004; Aubier et al. 1985; Hill et al. 1998). To mitigate this risk, therapeutic enteral nutrition(EN) is delivered via nasogastric(NGT), orogastric(OGT), or nasoenteric tube(NET) as soon as possible after admission to the intensive care unit(ICU) or upon restoration of gastrointestinal(GI) continuity. Despite these interventions, TSICU patients often suffer a calorie deficit associated with enteral nutrition interruption(ENI) for procedures or transitions in care(Peev et al. 2015; McClave et al. 2009). These periods of fasting predict quantified caloric deficit associated with complications of malnutrition(Peev et al. 2015; Segaran, Barker, and Hartle 2016). Reduction in ENI duration before and after ICU procedures has yielded decreased caloric deficits within mixed ICU populations(Segaran, Barker, and Hartle 2016).

When the need for EN is prolonged, percutaneous endoscopic gastrostomy tube(PEG) placement is a bedside procedure employed to promote progress toward rehabilitation and disposition out of the ICU. First described in 1980, the technique found its success in replacing the classic open gastrostomy performed through a laparotomy incision under general anesthesia(Gauderer, Ponsky, and Izant 1980). Approximately 100,000-125,000 PEGs are performed annually in the United States(Mendiratta et al. 2012). Despite 40 years of experience and its routine nature in modern critical care settings, there is little evidence on which to base timing of tube feeds after PEG placement in the mechanically ventilated Trauma and Surgical ICU(TSICU) population.

Pre- and post-PEG tube placement fasting practices are highly variable among surgical intensivists. There is no standard of care, despite truncated periods of periprocedural fasting described as safe in previously published retrospective and prospective observational studies. There is no evidence to support prolonged fasting after PEG placement in TSICU patients, thus an opportunity to improve patient outcomes by providing evidence that will encourage earlier feeding and a reduction in calorie deficits.The aim of the study is to encourage a standard of care among surgical intensivists that will help to mitigate the risk of malnutrition in this highly susceptible patient population.

Trauma and Surgical ICU patients undergoing bedside PEG tube placement will be randomized to one of two groups: FAST and noFAST. The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. The noFAST group will have post-PEG tube feeds initiated <1 hour after the procedure. Feeds for both are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Katie L. Bower, MD
  • Phone Number: 540-981-7434
  • Email: klbower@vt.edu

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with aberant 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: noFast: Start tube feeds within 1 hour of procedure
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.
Dietary supplement: noFast: Start tube feeds within 1 hour of procedure
Earliest possible initiation of tube feeding after bedside PEG tube procedure.
No Intervention: FAST: Start tube feeds 4 hours after procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hours fasted
Time Frame: 24 hours before to 72 hours after the procedure
Number of hours patients are not receiving prescribed caloric intake
24 hours before to 72 hours after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 0-72 hours after the procedure
Complications associated with timing to start tube feeds after bedside PEG placement
0-72 hours after the procedure
Calorie deficit
Time Frame: 24 hours to 72 hours after procedure
Cumulative calorie deficit acquired as a result of peri-procedural fasting
24 hours to 72 hours after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Katie L Bower, MD, Carilion Clinic, Virginia Tech Carilion School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2019

Primary Completion (Anticipated)

September 30, 2026

Study Completion (Anticipated)

September 30, 2026

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-355

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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