noFast: Start tube feeds within 1 hour of procedure for Mechanical Ventilation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mechanical Ventilation+6 MorenoFast: Start tube feeds within 1 hour of procedure - DietarySupplement
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Mechanical Ventilation
  • Critical Illness
  • Malnutrition
  • Gastrostomy
  • Procedural Complications
  • Trauma
  • Surgery

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 24 hours before to 72 hours after the procedure

Hour 72
Complications
Hour 72
Hours fasted
Hour 72
Calorie deficit

Trial Safety

Trial Design

4 Treatment Groups

noFast: Start tube feeds within 1 hour of procedure
1 of 4
FAST: Start tube feeds 4 hours after procedure
1 of 4
control FAST group
1 of 4
No Fast group
1 of 4

Active Control

1200 Total Participants · 4 Treatment Groups

Primary Treatment: noFast: Start tube feeds within 1 hour of procedure · No Placebo Group · N/A

noFast: Start tube feeds within 1 hour of procedure
DietarySupplement
ActiveComparator Group · 1 Intervention: noFast: Start tube feeds within 1 hour of procedure · Intervention Types: DietarySupplement
FAST: Start tube feeds 4 hours after procedureNoIntervention Group · 1 Intervention: FAST: Start tube feeds 4 hours after procedure · Intervention Types:
control FAST groupNoIntervention Group · 1 Intervention: control FAST group · Intervention Types:
No Fast groupActiveComparator Group · 1 Intervention: No Fast group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours before to 72 hours after the procedure

Who is running the clinical trial?

Carilion ClinicLead Sponsor
64 Previous Clinical Trials
11,168 Total Patients Enrolled
Virginia Polytechnic Institute and State UniversityOTHER
111 Previous Clinical Trials
24,613 Total Patients Enrolled
Katie L Bower, MDPrincipal InvestigatorCarilion Clinic, Virginia Tech Carilion School of Medicine

Eligibility Criteria

Age 18 - 100 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are mechanically ventilated surgical and trauma patients with clinical indication for PEG tube placement.
References