Early Feeding Following Percutaneous Gastrostomy Tube Placement

Study Overview
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Brief Summary
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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.

Official Title
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Early Feeding Following Percutaneous Gastrostomy Tube Placement

Conditions
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Gastrostomy

Intervention / Treatment
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* Other: Feeding at 4 hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early feeding<br>Patients randomized to early feeding will be fed 4 hours following gastrostomy tube placement | Other: Feeding at 4 hours<br>* Patients will be fed 4 hours after their gastrostomy tube placement procedure.<br>|
| No Intervention: Standard feeding<br>Patients randomized to standard feeding will be fed 24 hours following gastrostomy tube placement | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrostomy, Feeding, G-tube