Early Feeding Following Percutaneous Gastrostomy Tube Placement

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Gastrostomy

Treatments: Other: Feeding at 4 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT03319576

16-1074

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Early feeding

Experimental group

Description:

Patients randomized to early feeding will be fed 4 hours following gastrostomy tube placement

Treatment:

Other: Feeding at 4 hours

Standard feeding

No Intervention group

Description:

Patients randomized to standard feeding will be fed 24 hours following gastrostomy tube placement