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Completed

NCT Number: NCT03319576

Early Feeding Following Percutaneous Gastrostomy Tube Placement

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.

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Key information

Conditions

Gastrostomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding at 4 hours

Other

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

Primary outcomes

  1. Inability to feed

    Time frame: 4 hours after gastrostomy tube placement

    Inability to feed due to high pre-feeding gastric residual volume

  2. Changes in any major or minor complications

    Time frame: 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 outcomes

  1. Positive predictive value of computed tomography (CT) prior to gastrostomy tube placement will be measured at the end of the study.

    Time frame: At Study Completion, approximately 2 years

    Positive predictive value of CT prior to gastrostomy tube placement

  2. Procedural experience from the patients' perspective

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2017
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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