Clinical trial NCT03319576: Early Feeding Following Percutaneous Gastrostomy Tube Placement
Official title: Early Feeding Following Percutaneous Gastrostomy Tube Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Keywords: Gastrostomy
Feeding
G-tube
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Inability to feed
timeFrame: 4 hours after gastrostomy tube placement
measure: Changes in any major or minor complications
timeFrame: 24 hours after gastrostomy tube placement
Secondary outcomes:
measure: Positive predictive value of computed tomography (CT) prior to gastrostomy tube placement will be measured at the end of the study.
timeFrame: At Study Completion, approximately 2 years
measure: Procedural experience from the patients' perspective
timeFrame: 2 weeks after gastrostomy tube placement
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Premal Trivedi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: