Gastrostomy
Conditions
Keywords
Gastrostomy, Feeding, G-tube
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.
Interventions
OTHERFeeding at 4 hours
Patients will be fed 4 hours after their gastrostomy tube placement procedure.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed