跳至主要内容
临床试验/NCT04110613
NCT04110613招募中不适用

A Randomized Controlled Trial to Reduce Periprocedural Fasting in Ventilated Trauma and Surgical Intensive Care Patients

Carilion Clinic2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2019年9月19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
1,200
试验地点
2
主要终点
Hours fasted

研究概览

简要总结

Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.

详细描述

Trauma and surgical intensive care unit(TSICU) patients supported with mechanical ventilation are at high risk for complications associated with malnutrition (Ambrosino and Clini 2004; Aubier et al. 1985; Hill et al. 1998). To mitigate this risk, therapeutic enteral nutrition(EN) is delivered via nasogastric(NGT), orogastric(OGT), or nasoenteric tube(NET) as soon as possible after admission to the intensive care unit(ICU) or upon restoration of gastrointestinal(GI) continuity. Despite these interventions, TSICU patients often suffer a calorie deficit associated with enteral nutrition interruption(ENI) for procedures or transitions in care(Peev et al. 2015; McClave et al. 2009). These periods of fasting predict quantified caloric deficit associated with complications of malnutrition(Peev et al. 2015; Segaran, Barker, and Hartle 2016). Reduction in ENI duration before and after ICU procedures has yielded decreased caloric deficits within mixed ICU populations(Segaran, Barker, and Hartle 2016).

When the need for EN is prolonged, percutaneous endoscopic gastrostomy tube(PEG) placement is a bedside procedure employed to promote progress toward rehabilitation and disposition out of the ICU. First described in 1980, the technique found its success in replacing the classic open gastrostomy performed through a laparotomy incision under general anesthesia(Gauderer, Ponsky, and Izant 1980). Approximately 100,000-125,000 PEGs are performed annually in the United States(Mendiratta et al. 2012). Despite 40 years of experience and its routine nature in modern critical care settings, there is little evidence on which to base timing of tube feeds after PEG placement in the mechanically ventilated Trauma and Surgical ICU(TSICU) population.

Pre- and post-PEG tube placement fasting practices are highly variable among surgical intensivists. There is no standard of care, despite truncated periods of periprocedural fasting described as safe in previously published retrospective and prospective observational studies. There is no evidence to support prolonged fasting after PEG placement in TSICU patients, thus an opportunity to improve patient outcomes by providing evidence that will encourage earlier feeding and a reduction in calorie deficits.The aim of the study is to encourage a standard of care among surgical intensivists that will help to mitigate the risk of malnutrition in this highly susceptible patient population.

Trauma and Surgical ICU patients undergoing bedside PEG tube placement will be randomized to one of two groups: FAST and noFAST. The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. The noFAST group will have post-PEG tube feeds initiated <1 hour after the procedure. Feeds for both are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult subjects over 18 years of age
  • Negative pregnancy test for women participants of child-bearing age
  • Mechanically ventilated surgical and trauma patients with clinical indication for PEG tube placement
  • Tolerating tube feeds at goal prior to procedure

排除标准

  • Patients with aberant gastrointestinal anatomy
  • Patients with gastrointestinal motility disorders
  • Patients with feeding intolerance prior to PEG tube procedure
  • Pregnant women, children, or other vulnerable populations
  • Clinical contraindications for PEG tube placement
  • PEG performed in setting other than ICU at bedside

结局指标

主要结局

Hours fasted

时间窗: 24 hours before to 72 hours after the procedure

Number of hours patients are not receiving prescribed caloric intake

次要结局

  • Calorie deficit(24 hours to 72 hours after procedure)
  • Complications(0-72 hours after the procedure)

研究者

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

Katie Love Bower

Principal Investigator

Carilion Clinic

研究点 (2)

Loading locations...

相似试验

RCT: Early Feeding After PEG Placement | 临床试验