Treatment of Dyspnea in Do-not-intubate Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2018 |
| Start Date: | April 2014 |
| End Date: | December 2019 |
| Contact: | Nicholas S Hill, MD |
| Email: | nhill@tuftsmedicalcenter.org |
| Phone: | 617-636-4288 |
Treatment of Dyspnea in Do-not-intubate (DNI) Patients
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.
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.
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.
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.
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
We found this trial at
2
sites
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Nicholas S Hill, MD
Phone: 617-636-4288
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
Click here to add this to my saved trials
Milan, 20122
Principal Investigator: Francesco Blasi, MD
Phone: +390250320627
Click here to add this to my saved trials