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Acute Respiratory Failure | Treatment of Dyspnea in Do-not-intubate Patients

Acute Respiratory Failure research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Respiratory Failure

Acute on Chronic Respiratory Failure

Dyspnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:NIVPatients treated, as per attending physician's decision, with noninvasive ventilation

Device:CPAPPatient treated, as per attending physician's decision, with CPAP

Device:Standard oxygenPatient 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:HFNCPatients 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

NIVPatients with acute respiratory failure or dyspnea and DNI order treated with noninvasive ventilation

CPAPPatients with dyspnea or acute respiratory failure and DNI order treated with continuous positive airways pressure (CPAP)

Standard oxygenPatients with dyspnea and/or acute respiratory failure and DNI order, treated with standard oxygen therapy either via face mask or nasal cannula

HFNCPatients with dyspnea and/or acute respiratory failure and DNI order treated with high-flow nasal cannula (HFNC).

Study Status

Recruiting

Start Date: April 2014

Completed Date: December 2019

Phase:

Type: Observational

Design:

Primary Outcome: Prevalence of use of Noninvasive ventilation in DNI patients

Secondary Outcome: Subjects' comfort

Study sponsors, principal investigator, and references

Principal Investigator: Nicholas S Hill, MD

Lead Sponsor: Tufts Medical Center

Collaborator: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

More information:https://clinicaltrials.gov/show/NCT02114944

Azoulay E, Kouatchet A, Jaber S, Lambert J, Meziani F, Schmidt M, Schnell D, Mortaza S, Conseil M, Tchenio X, Herbecq P, Andrivet P, Guerot E, Lafabrie A, Perbet S, Camous L, Janssen-Langenstein R, Collet F, Messika J, Legriel S, Fabre X, Guisset O, Touati S, Kilani S, Alves M, Mercat A, Similowski T, Papazian L, Meert AP, Chevret S, Schlemmer B, Brochard L, Demoule A. Noninvasive mechanical ventilation in patients having declined tracheal intubation. Intensive Care Med. 2013 Feb;39(2):292-301. doi: 10.1007/s00134-012-2746-2. Epub 2012 Nov 27.

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