Health TrialsbyHealthPanel

RCT: Early Feeding After PEG Placement

ConditionsCritical IllnessMalnutritionGastrostomyProcedural SequelaeTraumaSurgeryMechanical Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCarilion Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • noFast: Start tube feeds within 1 hour of procedure

    Dietary supplement

    Earliest possible initiation of tube feeding after bedside PEG tube procedure.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: noFast: Start tube feeds within 1 hour of procedureActive comparator 1 intervention
Group B: FAST: Start tube feeds 4 hours after procedureNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hours fasted

Number of hours patients are not receiving prescribed caloric intake

Time frame
24 hours before to 72 hours after the procedure

Secondary outcomes

1

Complications

Complications associated with timing to start tube feeds after bedside PEG placement

Time frame
0-72 hours after the procedure
2

Calorie deficit

Cumulative calorie deficit acquired as a result of peri-procedural fasting

Time frame
24 hours to 72 hours after procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carilion Clinic

Lead sponsor

Virginia Polytechnic Institute and State University

Collaborator

Source ClinicalTrials.gov
Apply now