Early Feeding Following Percutaneous Gastrostomy Tube Placement

Gastrostomy Clinical Trial

Official title:

Early Feeding Following Percutaneous Gastrostomy Tube Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319576
• Other study ID #: 16-1074
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: October 16, 2019

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Other:
• Feeding at 4 hours
Patients will be fed 4 hours after their gastrostomy tube placement procedure.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inability to feed	Inability to feed due to high pre-feeding gastric residual volume	4 hours after gastrostomy tube placement
Primary	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	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
Secondary	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