Early Feeding Following Percutaneous Gastrostomy Tube Placement

This study plans to learn more about the safety of early feeding following placement of a feeding tube. Doctors in other specialties feed patients 4 hours after patients receive a feeding tube. However, Interventional Radiologists typically wait to feed patients for 24 hours following feeding tube placement. The investigator would like to demonstrate that feeding after 4 hours does not increase complications and can actually reduce the burden to patients who receive a feeding tube.

Study Overview

• Status: Completed
• Conditions: Gastrostomy
• Intervention / Treatment: Other: Feeding at 4 hours

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients between the ages of 18-80 years
• Outpatients receiving a gastrostomy tube at University of Colorado that do not require post-pyloric feeding
• Patients that have no contraindication for intragastric feeding immediately following tube placement
• INR (international normalized ratio) <1.5
• Platelet count > 50,000/µL
• WBC (white blood cell count) 4.0-11.1 x 109/L

Exclusion Criteria:

• Patients < 18 years or > 80 years of age
• Patients admitted to the hospital at the time of screening (i.e., inpatients)
• Women who are pregnant (confirmed by urine pregnancy screen)
• Patients requiring post-pyloric feeding
• Patients receiving venting gastrostomy tubes
• Patients receiving primary Gastro-Jejunal (GJ) Tube tube placement
• Patients with an interposed bowel on CT after stomach insufflation
• INR > 1.5
• Platelet count < 50,000/µL
• WBC > 11.1 x 109/L
• Known active infection
• Need for post-gastric feeding
• History of gastric bypass surgery or Roux-En-Y
• Mechanical obstruction of the GI tract
• Active peritonitis
• Known hemodynamic instability as demonstrated by tachycardia, hypotension, labile blood pressure or altered mental status.
• Bowel ischemia
• Ascites
• Recent Gastro-Intestinal (GI) bleeding (within 2 weeks)
• Respiratory compromise as demonstrated by hypercarbia (CO2>45mmHg) or hypoxia (O2<90%)
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early feeding; Patients randomized to early feeding will be fed 4 hours following gastrostomy tube placement	Other: Feeding at 4 hours; Patients will be fed 4 hours after their gastrostomy tube placement procedure.
No Intervention: Standard feeding; Patients randomized to standard feeding will be fed 24 hours following gastrostomy tube placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inability to feed	Inability to feed due to high pre-feeding gastric residual volume	4 hours after gastrostomy tube placement
Changes in any major or minor complications	Any change(s) noted in any major and/or minor complications arising post gastrostomy tube placement will be evaluated.	24 hours after gastrostomy tube placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of computed tomography (CT) prior to gastrostomy tube placement will be measured at the end of the study.	Positive predictive value of CT prior to gastrostomy tube placement	At Study Completion, approximately 2 years
Procedural experience from the patients' perspective	Patients will be asked to complete a survey related to tube usage and difficulties with feeding and immediate post-procedural complications	2 weeks after gastrostomy tube placement

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Premal Trivedi, MD, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Feeding; Gastrostomy; G-tube
• Other Study ID Numbers: 16-1074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data outside of the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No