Status:
COMPLETED
Early Feeding Following Percutaneous Gastrostomy Tube Placement
Lead Sponsor:
University of Colorado, Denver
Conditions:
Gastrostomy
Eligibility:
All Genders
18-80 years
Phase:
NA
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. Howeve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03319576
Start Date
October 30 2017
End Date
October 16 2019
Last Update
October 23 2019
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045