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Treatment of Dyspnea in Do-not-intubate Patients

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ClinicalTrials.gov Identifier: NCT02114944
Recruitment Status : Recruiting
First Posted : April 15, 2014
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Tufts Medical Center

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.


Condition or disease Intervention/treatment
Acute Respiratory Failure Acute on Chronic Respiratory Failure Dyspnea Device: NIV Device: CPAP Device: Standard oxygen Device: HFNC

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Dyspnea in Do-not-intubate (DNI) Patients
Actual Study Start Date : April 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
NIV
Patients with acute respiratory failure or dyspnea and DNI order treated with noninvasive ventilation
Device: NIV
Patients treated, as per attending physician's decision, with noninvasive ventilation

Device: Standard oxygen
Patient treated, as per attending physician's decision with standard oxygen therapy either as primary respiratory therapy or rest therapy during breaks off CPAP or NIV

Device: HFNC
Patients treated, as per attending physician's decision, with high-flow nasal cannula either as primary therapy or rest therapy during breaks off NIV or CPAP
Other Name: High-flow nasal cannula

CPAP
Patients with dyspnea or acute respiratory failure and DNI order treated with continuous positive airways pressure (CPAP)
Device: CPAP
Patient treated, as per attending physician's decision, with CPAP

Device: Standard oxygen
Patient treated, as per attending physician's decision with standard oxygen therapy either as primary respiratory therapy or rest therapy during breaks off CPAP or NIV

Device: HFNC
Patients treated, as per attending physician's decision, with high-flow nasal cannula either as primary therapy or rest therapy during breaks off NIV or CPAP
Other Name: High-flow nasal cannula

Standard oxygen
Patients with dyspnea and/or acute respiratory failure and DNI order, treated with standard oxygen therapy either via face mask or nasal cannula
Device: Standard oxygen
Patient treated, as per attending physician's decision with standard oxygen therapy either as primary respiratory therapy or rest therapy during breaks off CPAP or NIV

HFNC
Patients with dyspnea and/or acute respiratory failure and DNI order treated with high-flow nasal cannula (HFNC).
Device: HFNC
Patients treated, as per attending physician's decision, with high-flow nasal cannula either as primary therapy or rest therapy during breaks off NIV or CPAP
Other Name: High-flow nasal cannula




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

Secondary Outcome Measures :
  1. Subjects' comfort [ Time Frame: Day 1 to 5 ]
    To define subjects' comfort based on the treatment they are receiving

  2. Dyspnea score [ Time Frame: Day 1 to 5 ]
    To define the dyspnea score based on the treatment the subjects are receiving

  3. Family members' impressions [ Time Frame: Day 3 ]
    Collect family members' impression on the respiratory device chosen to treat dyspnea and acute respiratory failure

  4. Family member's impressions [ Time Frame: Day 30 ]
    Collect family members' impression on the respiratory device chosen to treat dyspnea and acute respiratory failure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114944


Contacts
Contact: Nicholas S Hill, MD 617-636-4288 nhill@tuftsmedicalcenter.org
Contact: Giulia Spoletini, MD 617-636-5293 GSpoletini@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02116
Contact: Nicholas S Hill, MD    617-636-4288    nhill@tuftsmedicalcenter.org   
Contact: Alia Khoja, MD    617-636-5293    AKhoja@tuftsmedicalcenter.org   
Principal Investigator: Nicholas S Hill, MD         
Sub-Investigator: Giulia Spoletini, MD         
Sub-Investigator: Mona Alotaibi, MD         
Sub-Investigator: Alia Khoja, MD         
Sub-Investigator: Chiara Mega, MD         
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy, 20122
Contact: Francesco Blasi, MD    +390250320627    francesco.blasi@unimi.it   
Principal Investigator: Francesco Blasi, MD         
Sub-Investigator: Marco Mantero, MD         
Sub-Investigator: Giulia Spoletini, MD         
Sponsors and Collaborators
Tufts Medical Center
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Study Director: Nicholas S Hill, MD Tufts Medical Center

Publications:

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02114944     History of Changes
Other Study ID Numbers: IRB-11227
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Tufts Medical Center:
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

Additional relevant MeSH terms:
Respiratory Insufficiency
Dyspnea
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases