Early Feeding Following Percutaneous Gastrostomy Tube Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Inability to feed
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Early feeding
Patients randomized to early feeding will be fed 4 hours following gastrostomy tube placement
干预措施: Feeding at 4 hours (Other)
Standard feeding
Patients randomized to standard feeding will be fed 24 hours following gastrostomy tube placement
结局指标
主要结局
Inability to feed
时间窗: 4 hours after gastrostomy tube placement
Inability to feed due to high pre-feeding gastric residual volume
Changes in any major or minor complications
时间窗: 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.
次要结局
- Procedural experience from the patients' perspective(2 weeks after gastrostomy tube placement)
- 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)