Clinical trial NCT02114944: Treatment of Dyspnea in Do-not-intubate Patients
Official title: Treatment of Dyspnea in Do-not-intubate (DNI) Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Failure
Acute on Chronic Respiratory Failure
Dyspnea
Keywords: Do-not-intubate
DNI
Palliative treatment
Acute respiratory failure
Acute on chronic respiratory failure
Hypoxia
Respiratory acidosis
Hypercarbia
Non invasive ventilation
NIV
CPAP
Oxygen-therapy
High-flow oxygen therapy
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2014-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted to study center will be screened for study entry. Patients with dyspnea and/or acute respiratory failure (regardless the underlying diagnosis) and with a DNI order will be evaluated to define study entry criteria.

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 description: 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.

Some data (demographics, medications, vitals, arterial blood gas, history of present illnes and past medical history, treatment plan) will be extracted from medical records. A daily assessment of dyspnea score (Numeric rating scale, (NRS)), comfort (NRS) and pain (NRS) will be performed. Patients and family members will be asked to fill in a questionnaire at day 3. Heal care providers (attending physician, nurse and RT) will be asked to fill in a questionnaire at discharge. Family members and/or patients will be contacted by phone 30 days after discharge to get additional information about patient's outcome.

Research plan: Demographics and baseline characteristics of patients will be summarized for each group overall and by cohorts (DNI on NIV, DNI on CPAP, DNI with no ventilator support). Continuous variables will be reported as mean ± standard deviation. Categorical variables will be reported as n and %. For the primary outcome, a one-way ANOVA will be used to compare the difference in means between the groups. If the data are not normally distributed, the Krusman-Wallis test will be performed. Regression analysis will also be conducted to evaluate the consistency of treatment effects across the cohorts, controlling for potential confounding factors at baseline.

A Chi-square test (or Fisher's exact test if the counts are below 5) will be used to compare the distribution of categorical outcomes between the groups. Where appropriate, generalized linear models will be fitted with categorical and count data to evaluate the consistency of treatment effects across the cohorts, controlling for potential confounding factors at baseline.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No exclusion criteria

Termination criteria:

* Withdraw DNI order

Primary outcomes:
measure: Prevalence of use of Noninvasive ventilation in DNI patients
timeFrame: Day 1
Secondary outcomes:
measure: Subjects' comfort
timeFrame: Day 1 to 5
measure: Dyspnea score
timeFrame: Day 1 to 5
measure: Family members' impressions
timeFrame: Day 3
measure: Family member's impressions
timeFrame: Day 30
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Tufts Medical Center
name: Nicholas S Hill, MD
role: STUDY_DIRECTOR
References:
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