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临床试验/NCT01301352
NCT01301352已完成不适用

The Efficacy and Safety of Gastric Feeding in Critically Ill Pediatric Patients Receiving Non-invasive Positive Pressure Ventilation: A Pilot Study

McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
The percent goal enteral calories received while receiving NPPV

研究概览

简要总结

The investigators are studying whether it is safe and effective to provide enteral nutrition to critically ill children via the nasogastric route, as opposed to the nasojejunal route, while they are receiving noninvasive positive pressure ventilation.

详细描述

It has been our experience that the placement of post-pyloric tubes can be difficult, and that these tubes frequently become obstructed and are difficult to replace, resulting in lost caloric intake for the patient. The population where this is most relevant is children receiving Noninvasive Positive Pressure Ventilation (NPPV). NPPV has become increasingly popular in the Pediatric Intensive Care Unit (PICU) population, due to its perception as a safe and effective alternative to mechanical ventilation via an endotracheal tube. Historically, NPPV has been used in children with chronic respiratory insufficiency, but its application for acute respiratory compromise is increasing. It has been shown to be effective in disease states associated with hypoventilation, and is now also being applied to respiratory problems leading to decreased oxygenation. Infants and children receiving noninvasive ventilation for respiratory failure, which is often infectious in origin, have significant caloric needs. However, it is our practice not to allow gastric feeding in these patients due to the fear of gastric distension and vomiting, which carries a risk of aspiration.

There is no data available on the question of efficacy and safety of gastric feeding in critically-ill children supported by noninvasive ventilation. Given the ease of (re)placement, and the potential nutritional benefit of earlier feeding provided by gastric feeding, it seems clinically important to question the bias against this route of enteral nutrition in noninvasively ventilated patients. The investigators therefore propose a pilot randomized trial of gastric versus post-pyloric feeds in patients on NPPV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age under 18 years old
  • •Acute respiratory failure as the indication for non-invasive ventilatory support
  • •Signed consent from parent or guardian
  • •Patients with a feeding tube in place who have not been fed in > 12 hours

排除标准

  • •Immediate postoperative cardiac surgery
  • •Chronic ventilatory support
  • •Admission diagnosis of aspiration pneumonia
  • •Known history of frequent aspiration (more than 2 previous admissions for this diagnosis)
  • •Contraindication to feeding tube placement (e.g. basal skull fracture)
  • •Imminent need for endotracheal intubation
  • •Percutaneous gastric tube in place
  • •History of Nissen fundoplication
  • •Contraindication to study nutritional formulas (e.g. galactosemia)
  • •Allergy to metoclopramide
  • •No signed consent from parent or guardian
  • •Continuous Positive Airway Pressure (CPAP) with or without pressure support administered via an endotracheal tube
  • •Corrected gestational age under 38 weeks
  • •Patients with a feeding tube in place who have been fed within the last 12 hours
  • •Patients with a feeding tube in place in whom the PICU staff do not wish to change the position of the feeding tube (i.e. do not agree to randomize the patient's feeding tube position)

研究组 & 干预措施

Nasojejunal feeding (control)

No Intervention

Nasogastric feeding (intervention)

Experimental

干预措施: Route of feeding (nasogastric vs. nasojejunal) (Other)

结局指标

主要结局

The percent goal enteral calories received while receiving NPPV

时间窗: Daily up to 14 days

Daily percent goal calories are recorded. Also total percent goal calories over entire NPPV course.

次要结局

  • The time required to achieve goal calories while on NPPV(Hours (estimated up to 48 hours))
  • The length of stay in ICU and in hospital(Days (estimated up to 14 and 28 days, respectively))
  • Episodes of clinically important gastric aspiration(Episodes (number - up to 1 per subject))

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Allon Beck

Dr.

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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