Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Enteral nutrition delivered/Enteral nutrition prescribed x 100
研究概览
简要总结
Enteral nutrition is considered the best way to feed those who can´t be fed orally. the standard protocol of administration includes continuous infusion for 24 hours; nonetheless this support is constantly suspended which causes a decrease in the nutrition administered vs the one formulated.
Therefore this randomized clinical trial attempts to compare de standard administration vs. cyclic infusion during night hours measuring the formulated vs the administered volume of enteral nutrition given to the patient.
The control group will be assigned standard 24 hour infusion of enteral nutrition while the experimental group will be assigned cyclic infusion during night hours. The variables include volume formulated, volume given in 24 hours, hours and reasons why the enteral nutrition was suspended, and related complications (abdominal distension, vomiting, and diarrhea).
详细描述
The trial will be carried at San Ignacio University Hospital intensive care unit. Patients included will be over 18 years old who require enteral nutrition according to their attending or to the nutritional and metabolic support team.
260 envelopes with the specific intervention were created. 130 of them are identified with number 0 which corresponds to no intervention, meaning continuous enteral nutrition infusion during 24 hours. The other 130 are assigned with the number 1 which corresponds to intervention, meaning nocturnal cyclic nocturnal enteral nutrition infusion.
Envelopes will be randomly assigned sequentially from number 1 to 260, in which envelope number 1 will be assigned for the first patient. Each patient´s envelope will be labeled with its name and identification number. According to the information contained in the envelope the specific scheme assigned will be formulated.
Envelopes will be kept at the Nutritional and metabolic support´s office; only research assistant will have access to this information.
After 50% of the sample be achieved, there will be a data analysis to review the rate of intolerance to enteral nutrition in both groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will be in the intensive care unit under sedative treatment and will not know about randomization Nurses in the intensive care unit (care providers of enteral nutrition infusion) will not know about the study Outcomes evaluation will be made by one independent clinical epidemiologist
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old, hospitalized in San Ignacio University Hospital intensive care unit.
- •Patients with indication on enteral nutrition defined by its attending or by the Nutritional and Metabolic support team.
排除标准
- •If patient or legal advocate denies to sign consent to participate in this study.
研究组 & 干预措施
Continuous infusion
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
干预措施: Continuous enteral nutrition infusion (Other)
Cyclic infusion
Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.
干预措施: Cyclic enteral nutrition infusion (Other)
结局指标
主要结局
Enteral nutrition delivered/Enteral nutrition prescribed x 100
时间窗: 24 hours
Enteral nutrition delivered/Enteral nutrition prescribed x 100
次要结局
- Enteral nutrition intolerance(24 hours)