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临床试验/NCT02604043
NCT02604043终止不适用

Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Number of times pH drops below 5.5.

研究概览

简要总结

This is a pilot prospective cohort study of the incidence of supraglottic pH readings.

详细描述

Aspiration is a serious morbidity that leads to an increase in both patient mortality and duration of hospital stays. Many practices exist within the hospital setting whose goal is to help prevent clinically significant aspiration including preoperative starvation, pharmaceutically reducing gastric acidity, facilitating gastric drainage, postural changes, cricoid pressure, endotracheal cuff pressure modification, and maintenance of a competent lower esophageal sphincter. However, to date, no monitoring system exists to help a clinician identify active aspiration. At present, video fluoroscopy, is the gold standard for detecting aspiration. This pilot prospective cohort study will examine the incidence of supraglottic pH readings.

A continuous pH/impedence sensor will be placed immediately above the glottic opening in four high risk populations: burn patients who are intubated, intubated post-stroke patients, patients undergoing robotic prostectomy, and in patients undergoing peritoneal tumor debulking and chemotherapy. The presence of acidic fluid above the glottic opening will be measured using a supraglottic impendence/pH probe attached to an endotracheal tube.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Patients who are scheduled to undergo robotic prostatectomy.
  • Patients undergoing peritoneal tumor debulking and chemotherapy
  • Mechanically ventilated Burn Intensive Care Unit (BICU) Patients
  • Mechanically ventilated Neuro Care Unit (NCU) Patients who have suffered a stroke

排除标准

  • ICU patients who are not receiving enteral feeds
  • Patients who present for tumor debulking or robotic prostatectomy who receive preoperative H2 blockers, proton pump inhibitors, antacids or metoclopramide.

结局指标

主要结局

Number of times pH drops below 5.5.

时间窗: 24 hours period after placement of pH probe

次要结局

  • The mean of the angle (degrees) of the patient from the lateral position during low pH periods(24 hours period after placement of pH probe)

研究者

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

Bret Alvis

Assistant Professor Anesthesiology Critical Care Medicine

Vanderbilt University

研究点 (2)

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