Early Feeding Following Percutaneous Gastrostomy Tube Placement

Not Applicable

Completed

• Conditions: Gastrostomy
• Interventions: Other: Feeding at 4 hours

• Registration Number: NCT03319576
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-24
• Study Start: 2017-10-30
• Status Verified: 2019-10
• Primary Completion: 2019-10-16
• Study Completion: 2019-10-16
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early feeding	Feeding at 4 hours	Patients randomized to early feeding will be fed 4 hours following gastrostomy tube placement

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States