Acute Respiratory FailureNCT02114944
Treatment of Dyspnea in Do-not-intubate Patients
An observational study of Acute Respiratory Failure and Acute on Chronic Respiratory Failure, run by Tufts Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Acute on Chronic Respiratory Failure, Dyspnea
- What is being tested?
- NIV, CPAP and Standard oxygen
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2014to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No exclusion criteria
- Termination criteria:
- Withdraw DNI order
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
About this study
Official title: 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.
Read the 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.
- Being tested
- NIV, CPAP, Standard oxygen, HFNC
- 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
- Medical subject headings
- Dyspnea, Hypoxia, Acidosis, Respiratory, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVDevice
Patients treated, as per attending physician's decision, with noninvasive ventilation
CPAPDevice
Patient treated, as per attending physician's decision, with CPAP
Standard oxygenDevice
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
HFNCDevice
Also called High-flow nasal cannula
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
| Study group | Role | What they receive |
|---|---|---|
| NIV | Patients with acute respiratory failure or dyspnea and DNI order treated with noninvasive ventilation Receives: 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) Receives: 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 Receives: Device: Standard oxygen | |
| HFNC | Patients with dyspnea and/or acute respiratory failure and DNI order treated with high-flow nasal cannula (HFNC). Receives: Device: HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of use of Noninvasive ventilation in DNI patients
Measured: Day 1
Secondary outcomes (4)
Subjects' comfort
To define subjects' comfort based on the treatment they are receiving
Measured: Day 1 to 5
Dyspnea score
To define the dyspnea score based on the treatment the subjects are receiving
Measured: Day 1 to 5
Family members' impressions
Collect family members' impression on the respiratory device chosen to treat dyspnea and acute respiratory failure
Measured: Day 3
Family member's impressions
Collect family members' impression on the respiratory device chosen to treat dyspnea and acute respiratory failure
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion1 Sep 2020
- Study completion1 Dec 2023
Why it stopped: The pandemic shut down study activity and due to personnel problems and retirement of our main collaborator, we were unable to resume afterwards.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas S Hill, MD, Study director, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114944
- Sponsor's protocol ID
- IRB-11227
- Status last verified
- May 2025
- First submitted
- 11 Apr 2014
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23184037Sinuff 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.
PubMed 18209669Nava 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.
PubMed 17601972Puntillo 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.
PubMed 24275901Curtis 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.
PubMed 17255876Organized 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.
PubMed 11208659Levy 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.
PubMed 15483407Schettino 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.
PubMed 16148468Nava 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.
PubMed 23406914
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dyspnea in Do-not-intubate (DNI) Patients
- ClinicalTrials.gov ID
- NCT02114944
- Acronym / sponsor ID
- IRB-11227
- Keywords
- Do-not-intubate, DNI, Palliative treatment, Acute respiratory failure, Acute on chronic respiratory failure, Hypoxia, Respiratory acidosis, Hypercarbia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The pandemic shut down study activity and due to personnel problems and retirement of our main collaborator, we were unable to resume afterwards.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- Apr 2014 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NIV | – | Device: NIV, Device: Standard oxygen, Device: HFNCPatients with acute respiratory failure or dyspnea and DNI order treated with noninvasive ventilation |
| CPAP | – | Device: CPAP, Device: Standard oxygen, Device: HFNCPatients with dyspnea or acute respiratory failure and DNI order treated with continuous positive airways pressure (CPAP) |
| Standard oxygen | – | Device: Standard oxygenPatients with dyspnea and/or acute respiratory failure and DNI order, treated with standard oxygen therapy either via face mask or nasal cannula |
| HFNC | – | Device: HFNCPatients with dyspnea and/or acute respiratory failure and DNI order treated with high-flow nasal cannula (HFNC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- No exclusion criteria
- Withdraw DNI order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIVPatients treated, as per attending physician's decision, with noninvasive ventilation | Device | NIV |
| CPAPPatient treated, as per attending physician's decision, with CPAP | Device | CPAP |
| 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 | CPAP, NIV, Standard oxygen |
| HFNCAlso: High-flow nasal cannulaPatients 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 | Device | CPAP, HFNC, NIV |
Primary outcome
Prevalence of use of Noninvasive ventilation in DNI patients
Time frame: Day 1
4 secondary outcomes
Subjects' comfort
Time frame: Day 1 to 5
Dyspnea score
Time frame: Day 1 to 5
Family members' impressions
Time frame: Day 3
Family member's impressions
Time frame: Day 30
Results and safety
The study was stopped early (reason given: The pandemic shut down study activity and due to personnel problems and retirement of our main collaborator, we were unable to resume afterwards.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 23184037Azoulay 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.
- Background: PubMed 18209669Sinuff 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.
- Background: PubMed 17601972Nava 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.
- Background: PubMed 24275901Puntillo 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.
- Background: PubMed 17255876Curtis 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.
- Background: PubMed 11208659Organized 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.
- Background: PubMed 15483407Levy 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.
- Background: PubMed 16148468Schettino 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.
- Background: PubMed 23406914Nava 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas S Hill, MD study director
Tufts Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Acute on Chronic Respiratory Failure, run by Tufts Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The pandemic shut down study activity and due to personnel problems and retirement of our main collaborator, we were unable to resume afterwards.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of use of Noninvasive ventilation in DNI patients (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114944, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.