Treatment of Dyspnea in Do-not-intubate Patients

NCT02114944 | Terminated

• 1 other identifier: IRB-11227
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of use of Noninvasive ventilation in DNI patients

  Day 1

Secondary Outcomes (4)

• Subjects' comfort

  Day 1 to 5

• Dyspnea score

  Day 1 to 5

• Family members' impressions

  Day 3

• Family member's impressions

  Day 30

Study Arms (4)

NIV

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

Device: NIV; Device: Standard oxygen; Device: HFNC

CPAP

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

Device: CPAP; Device: Standard oxygen; Device: HFNC

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

HFNC

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

Device: HFNC

Interventions

NIV DEVICE

Patients treated, as per attending physician's decision, with noninvasive ventilation

NIV

CPAP DEVICE

Patient treated, as per attending physician's decision, with CPAP

CPAP

Standard oxygen DEVICE

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

CPAP; NIV; Standard oxygen

HFNC DEVICE

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

Also known as: High-flow nasal cannula

CPAP; HFNC; NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Termination criteria:
• Withdraw DNI order

Sponsors & Collaborators

• Tufts Medical Center: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02116, United States

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (9)

• 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.

  PMID: 23184037 BACKGROUND

• Sinuff T, Cook DJ, Keenan SP, Burns KE, Adhikari NK, Rocker GM, Mehta S, Kacmarek R, Eva K, Hill NS. Noninvasive ventilation for acute respiratory failure near the end of life. Crit Care Med. 2008 Mar;36(3):789-94. doi: 10.1097/CCM.0B013E3181653584.

  PMID: 18209669 BACKGROUND

• Nava S, Sturani C, Hartl S, Magni G, Ciontu M, Corrado A, Simonds A; European Respiratory Society Task Force on Ethics and decision-making in end stage lung disease. End-of-life decision-making in respiratory intermediate care units: a European survey. Eur Respir J. 2007 Jul;30(1):156-64. doi: 10.1183/09031936.00128306.

  PMID: 17601972 BACKGROUND

• Puntillo K, Nelson JE, Weissman D, Curtis R, Weiss S, Frontera J, Gabriel M, Hays R, Lustbader D, Mosenthal A, Mulkerin C, Ray D, Bassett R, Boss R, Brasel K, Campbell M. Palliative care in the ICU: relief of pain, dyspnea, and thirst--a report from the IPAL-ICU Advisory Board. Intensive Care Med. 2014 Feb;40(2):235-248. doi: 10.1007/s00134-013-3153-z. Epub 2013 Nov 26.

  PMID: 24275901 BACKGROUND

• Curtis JR, Cook DJ, Sinuff T, White DB, Hill N, Keenan SP, Benditt JO, Kacmarek R, Kirchhoff KT, Levy MM; Society of Critical Care Medicine Palliative Noninvasive Positive VentilationTask Force. Noninvasive positive pressure ventilation in critical and palliative care settings: understanding the goals of therapy. Crit Care Med. 2007 Mar;35(3):932-9. doi: 10.1097/01.CCM.0000256725.73993.74.

  PMID: 17255876 BACKGROUND

• Organized jointly by the American Thoracic Society, the European Respiratory Society, the European Society of Intensive Care Medicine, and the Societe de Reanimation de Langue Francaise, and approved by ATS Board of Directors, December 2000. International Consensus Conferences in Intensive Care Medicine: noninvasive positive pressure ventilation in acute Respiratory failure. Am J Respir Crit Care Med. 2001 Jan;163(1):283-91. doi: 10.1164/ajrccm.163.1.ats1000. No abstract available.

  PMID: 11208659 BACKGROUND

• Levy M, Tanios MA, Nelson D, Short K, Senechia A, Vespia J, Hill NS. Outcomes of patients with do-not-intubate orders treated with noninvasive ventilation. Crit Care Med. 2004 Oct;32(10):2002-7. doi: 10.1097/01.ccm.0000142729.07050.c9.

  PMID: 15483407 BACKGROUND

• Schettino G, Altobelli N, Kacmarek RM. Noninvasive positive pressure ventilation reverses acute respiratory failure in select "do-not-intubate" patients. Crit Care Med. 2005 Sep;33(9):1976-82. doi: 10.1097/01.ccm.0000178176.51024.82.

  PMID: 16148468 BACKGROUND

• Nava S, Ferrer M, Esquinas A, Scala R, Groff P, Cosentini R, Guido D, Lin CH, Cuomo AM, Grassi M. Palliative use of non-invasive ventilation in end-of-life patients with solid tumours: a randomised feasibility trial. Lancet Oncol. 2013 Mar;14(3):219-27. doi: 10.1016/S1470-2045(13)70009-3. Epub 2013 Feb 11.

  PMID: 23406914 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Hypoxia; Acidosis, Respiratory; Hypercapnia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicholas S Hill, MD

  Tufts Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2023
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1); IT (1)