Early Feeding Following Percutaneous Gastrostomy Tube Placement

NCT ID: NCT03319576

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2019-10-16

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.

Conditions

Gastrostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early feeding

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

Group Type: EXPERIMENTAL

Feeding at 4 hours

Intervention Type: OTHER

Patients will be fed 4 hours after their gastrostomy tube placement procedure.

Standard feeding

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Feeding at 4 hours

Patients will be fed 4 hours after their gastrostomy tube placement procedure.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Premal Trivedi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

16-1074

Identifier Type: -

Identifier Source: org_study_id