Clinical Trial: Treatment of Dyspnea in Do-not-intubate Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary:

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.

Detailed Summary:

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/
Sponsor: Tufts Medical Center

Current Primary Outcome: Prevalence of use of Noninvasive ventilation in DNI patients [ Time Frame: Day 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Subjects' comfort [ Time Frame: Day 1 to 5 ]
  To define subjects' comfort based on the treatment they are receiving
• Dyspnea score [ Time Frame: Day 1 to 5 ]
  To define the dyspnea score based on the treatment the subjects are receiving
• Family members' impressions [ Time Frame: Day 3 ]
  Collect family members' impression on the respiratory device chosen to treat dyspnea and acute respiratory failure
• Family member's impressions [ Time Frame: Day 30 ]
  Collect family members' impression on the respiratory device chosen to treat dyspnea and acute respiratory failure

Original Secondary Outcome: Same as current

Information By: Tufts Medical Center

Dates:
Date Received: April 11, 2014
Date Started: April 2014
Date Completion: December 2019
Last Updated: January 19, 2017
Last Verified: January 2017