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临床试验/NCT02114944
NCT02114944终止不适用

Treatment of Dyspnea in Do-not-intubate (DNI) Patients

Tufts Medical Center2 个研究点 分布在 2 个国家目标入组 400 人开始时间: 2014年4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
400
试验地点
2
主要终点
Prevalence of use of Noninvasive ventilation in DNI patients

研究概览

简要总结

Patients with severe chronic diseases are often admitted to the hospital complaining of shortness of breath. Some of these patients decide that they do not want placement of a breathing tube in the windpipe to assist their breathing. In this situation, these patients are treated with oxygen, a variety of medications like morphine or masks that are connected to breathing machines, something called bilevel positive airway pressure (BiPAP) or noninvasive ventilation (NIV), to help with their breathing. Not much is known about how much noninvasive ventilation helps these patients, especially how comfortable they feel with it and how much their families think it helps.

Our aim is to monitor use of ways to help breathing in patients who don't want a breathing tube, see how often noninvasive ventilation is used and ask surviving patients, patient's families and caregivers about their experience with noninvasive ventilation and how much it seemed to help.

With our findings, we hope to improve the use of noninvasive ventilation in these patients and come up with ways to relieve their shortness of breath and provide as much comfort as possible.

详细描述

Background: Respiratory symptoms, dyspnea and acute respiratory failure are often reported in patients admitted to the Hospital with a do-not-intubate (DNI) order. These patients are routinely treated with medical therapy, sometimes to reverse the underlying process, but also often to achieve palliation. The therapies include opioids or anxiolytics, oxygen, CPAP and non-invasive ventilation (NIV) depending on the underlying disease.

Rationale: Considering that most of the available data on the palliative use of NIV are limited to short-term prognosis and are collected selecting DNI patients among those subjects already receiving NIV treatment. A prospective observational study focusing on therapies offered to patients entering the hospital with or switching to a DNI status during the hospitalization would be helpful to fill in the blanks regarding the current palliative treatment of dyspnea in critically ill DNI patients. The assessment of patients' symptoms and comfort and family members' perspective would be important to further understand how the discussion with healthcare proxies and families should be addressed in relation to end-of life-decisions. In addition, the collection of health care providers' impressions on the use of different treatments to alleviate dyspnea and respiratory distress in this situation could help to better understand how to implement palliative treatment of respiratory symptoms in DNI patients.

Our aim is to monitor and establish the prevalence of use of NIV among DNI patients and to assess patients, family members' and caregivers' perspectives on the patient's and their own experience of NIV relative to other approaches to palliating symptoms.

Study design: A prospective, observational study enrolling all consecutive patients with dyspnea and/or acute respiratory failure with DNI orders admitted to the study site.

Study procedures: Subjects participating in the study will be treated as per hospital procedure and according to the attending physician orders, to maintain oxygen saturation at the targeted level and to optimize patient comfort using anxiolytics and narcotics as indicated. No changes in the standard of care will be performed based on participation in the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 of 18 or more years of age
  • Patients presenting to the study site with dyspnea, respiratory distress and/or acute respiratory failure.
  • Patients who have or acquire a DNI order during their hospital stay
  • Consent to participate in the study

排除标准

  • No exclusion criteria
  • Termination criteria:
  • Withdraw DNI order

结局指标

主要结局

Prevalence of use of Noninvasive ventilation in DNI patients

时间窗: Day 1

次要结局

  • Dyspnea score(Day 1 to 5)
  • Subjects' comfort(Day 1 to 5)
  • Family members' impressions(Day 3)
  • Family member's impressions(Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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