跳至主要内容
临床试验/NCT05906472
NCT05906472招募中不适用

Prevent Unnecessary Surgeon Holds of Ingestions for Tracheostomy (PUSH-IT)

State University of New York at Buffalo12 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
12
主要终点
Rate of aspiration pneumonia

研究概览

简要总结

The goal of this clinical trial is to evaluate nutrition administration in the time around the tracheostomy in patients with breathing tubes. The main questions it aims to answer are:

  • Will continuing nutrition up to the time of surgery (tracheostomy) decrease nutrition interruptions, thereby increasing food intake?
  • Does continuing nutrition up to the time of surgery increase instances of food going into the lungs or lung infections?

Researchers will compare patients who have nutrition withheld 6 hours prior to surgery versus those who receive nutrition up until the time of surgery to see if there are differences in food intake, instances of food entering the lungs or lung infections.

详细描述

Malnutrition is a significant problem in the critically ill, however with busy operating room schedules, we often find that feeds are interrupted repetitively prior to elective surgery. These interruptions are practiced based on the American Society of Anesthesiologist guidelines for fasting intervals for elective surgery. These guidelines, however, were not created for critically ill, intubated patients. The theoretical concern for an increased risk of aspiration with continuation of enteral feeds up to the time of surgery persists without supporting evidence. Thus, there is a need for a universal evidence-based guideline on perioperative enteral feeding to benefit critical care patients.

To this end, the goal of the present study is to implement a protocol designed to decrease the interruption of enteral feeds in critical care patients undergoing tracheostomy and prospectively evaluate whether this leads to a quantitative increase in nutritional intake without increasing the risk of aspiration. Additionally, we hope that increasing quantitative nutrition may decrease morbidity especially in the small subset of patients where feed interruptions occur repetitively.

If the aims of the project are achieved, the data obtained from this study will be used to create an evidence-based platform from which physicians can practice. This will end the anecdotal controversy regarding perioperative tube feed management for tracheostomy; thereby increasing quantitative nutrition and hopefully improving the care of critically ill patients.

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

  • 18 years or older
  • admitted to the intensive care unit (ICU)
  • intubated and require tracheostomy

排除标准

  • under 18 years
  • unable to obtain informed consent
  • deemed clinically brain dead within 7 days of enrollment
  • transitioned to comfort measures within 7 days of enrollment
  • Pregnant patients
  • Prisoners

结局指标

主要结局

Rate of aspiration pneumonia

时间窗: Over 7 days from the time of tracheostomy

To assess differences in rates of aspiration events, a log-rank test for differences in survival curves model will be used. Assuming proportional hazards and non-informative censoring, a cox-model will be used to estimate follow-up hazard ratios for development of aspiration pneumonia between the two groups of interest.

次要结局

  • Volume of tube feed delivery(From day of consent to completion of study which is 7 days from the time of tracheostomy.)

研究者

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

Eden Nohra

Principal Investigator

State University of New York at Buffalo

研究点 (12)

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