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临床试验/NCT01383980
NCT01383980已完成不适用

A Randomized Trial of Continuous Versus Interrupted Enteral Feeding in Critically Ill Surgical Patients Requiring Mechanical Ventilation

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Total calories delivered

研究概览

简要总结

Surgical patients fed up until the point of surgery will have safe delivery of more calories compared to a group whose feeding is held at midnight prior to surgery.

详细描述

Nutrition is essential for healing and recovery from illness. Tube feeds are the standard care for patients with prolonged stays in the intensive care unit (ICU) who cannot eat food on their own. Tube feeding means that a tube has been placed in a patient's stomach or small intestine to provide nutrition.

When a patient is scheduled for an elective surgery, he/she usually has nothing to eat after midnight prior to the operation. A fasting period before surgery is done to avoid possible side effects during the placement of a breathing tube. Having an empty stomach is thought to decrease the chances of vomiting or aspiration while a breathing tube is placed. (Aspiration occurs when a substance, such as food provided by a tube feed, enters the airway.) However, some patients already have a breathing tube in place. The investigators do not know which is better for patients who already have a breathing tube in place: continuing feedings up until surgery or stopping them the night before.

The investigators hypothesize intubated surgical patients randomized to a protocol of feeding up until the point of surgery will have the safe delivery of more calories as compared to a group whose feeding is held at midnight prior to surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intubated with planned visit to the OR
  • Admitted to an ICU at OHSU
  • Receiving enteral nutrition or plan to start enteral nutrition

排除标准

  • Age less than 18 years
  • Unable to obtain consent from patient or ARR

研究组 & 干预措施

Control

No Intervention

Tube feeds are held night prior to elective surgery (standard of care)

Continuous Feeding

Experimental

Tube feeds are continued up until surgery. Subjects with a nasogastric tube will have their stomach contents emptied prior to surgery.

干预措施: Continuous Tube Feedings (Dietary Supplement)

结局指标

主要结局

Total calories delivered

时间窗: Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.

The total number of calories subject consume while receiving tube feeding.

次要结局

  • Laboratory values(Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.)
  • Weight change(Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant.)
  • number of infections and aspiration events(From date of randomization until the date of documented complication. Subjects will be followed until discharge in case of multiple complications. Date of discharge is estimated to be three (3) weeks post-admission on average.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laszlo Kiraly

Assistant Professor

Oregon Health and Science University

研究点 (2)

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