COPDNCT04210050
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
A study testing Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical., Arterial blood gas (ABG) and serum bicarbonate level and Overnight home oximetry and transcutaneous CO2 monitoring in people with COPD, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical., Arterial blood gas (ABG) and serum bicarbonate level and Overnight home oximetry and transcutaneous CO2 monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2020to Jul 2026
- Phase
- Interventional
- 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
Who may be able to join
- Signed informed consent prior to any study-mandated procedure.
- Male or female aged ≥ 18 years with advanced hypercapnic COPD
- FEV1 ≤ 50% predicted and
- Prolonged hypercapnia during the daytime, at rest, without O2 or ventilatory support, PaCO2 > 52 mmHg on ABG (performed off of NIPPV), compensated with pH > 7.30
- Willingness to use NIPPV treatment
- English speaking
- Women and minorities will be recruited in numbers reflecting representation in the Boston Metropolitan community which is approximately 84% Caucasian, 9% African American, 5% Hispanic American, and 2% Asian American, as the knowledge gained can apply to individuals of all ethnic background and gender.
- We do not wish to limit our sample to a highly selected group of patients, to allow for more generalizable results.
Who cannot join
- Subjects will be excluded from participation in the study for a history of:
- Significant sleep disordered breathing (AHI 4% ≥ 15 events/hour) or high clinical suspicion (BMI ≥ 35)
- Neuromuscular disease or other causes of hypoventilation
- Abnormalities of the thorax or lungs other than COPD
- Already treated with home NIPPV
- Unable to wean from ventilator during admission
Show all 14Show fewer
- Unable to wean from NIPPV, pH < 7.30
- Recent tracheotomy decannulation
- History of severe depression or bipolar disorder requiring prior hospitalization or suicide attempts or ideation
- Cognitive impairment (such as advanced dementia) that would limit ability to provide consent or to use NIPPV
- Active recreational drug use
- Unstable housing that would limit ability to use NIPPV
- Severe heart failure (New York Heart Association stage IV)
- Active/unstable CAD
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Implementation of a Precision Sleep Ventilation (PSV) Chronic Respiratory Failure Management Program for Patients With Advanced Hypercapnic COPD
Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.
The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.
Read the detailed description
The purpose of this protocol is to perform a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure. The study will focus on the primary end-points of time to hospital re-admission for acute exacerbation of COPD and/or an episode of acute on chronic hypercapnic respiratory failure, in addition to other clinically relevant outcomes including patient health-related quality of life, sleep quality indices, and gas exchange parameters. Approximately 300 BIDMC adult patients will be recruited and each patient monitored over a period of 12 months.
- Conditions
- COPD
- Being tested
- Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical., Arterial blood gas (ABG) and serum bicarbonate level, Overnight home oximetry and transcutaneous CO2 monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.Device
In the usual care plus NIPPV group, those able to undergo attended PSG will be titrated with volume targeted pressure support mode, aiming to lower the baseline TcCO2 by 10 mmHg. In some cases, the CO2 cannot be lowered by that amount on a single titration, but rather will decrease over time.
For those unable to undergo lab titration (too frail, no transportation, decline/refuse), NIPPV will be initiated with empiric settings based on nighttime home CO2 tracking and daytime ABG monitoring.
Arterial blood gas (ABG) and serum bicarbonate levelDiagnostic test
Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study
Overnight home oximetry and transcutaneous CO2 monitoringDiagnostic test
will be conducted at 1 and 6 months into the study (for subjects in the NIPPV plus usual care group, testing will be done while using the ventilator.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Other | Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. Receives: Diagnostic Test: Arterial blood gas (ABG) and serum bicarbonate level; Diagnostic Test: Overnight home oximetry and transcutaneous CO2 monitoring |
| Usual care plus NIPPV group only | Active comparator | Usual care for COPD based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines plus use of nocturnal ventilator device using the Breas VIVO 50 home ventilator, Breas Medical (or any newer models as available). Receives: Device: Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.; Diagnostic Test: Arterial blood gas (ABG) and serum bicarbonate level; Diagnostic Test: Overnight home oximetry and transcutaneous CO2 monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to readmission or death
time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death
Measured: within 12 months
Secondary outcomes (4)
Patient health related quality of life (HRQOL)
The RAND SF-36, a 36-question multiple choice QOL form will be used to assess general health perception. The questions target eight health domains or scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal/emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and one's perceived change in health.
There is a 2-step process used in scoring, such that the score for each of the scales represent the average for all item in the scale that were answered. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Next, items in the same scale are averaged together to create 8 scale scores. The lower the score the more disability and the higher the score the less disability.
Scores will be assessed at baseline, 3 and 12 months for usual care and usual care plus ventilation support for all subjects.
Measured: 12 months
Dyspnea scale
change in results of the Medical Research Council dyspnea scale, a categorical scale from 1-5, higher score =more limitation on daily activity due to breathlessness. Scores will be assessed at baseline, 3 and 12 months for usual care and usual care plus ventilation subjects.
Measured: 12 months
Gas exchange
Change in CO2 from ABG and serum bicarbonate
Measured: 12 months
General health status
St. George's Respiratory questionnaire, a 50 item questionnaire that measures health status in patients with COPD will be completed at baseline, and after 3 and 12 months in all subjects. For this questionnaire, a score of 0 = best QOL, and a score of 100 = worst QOL. The questions focus on three areas - symptoms, activity, and impact (psycho-social).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start30 Sep 2020 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Trial was not initiated due to COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The model is a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breas Medical S.A.R.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210050
- Sponsor's protocol ID
- 2019P000778
- Status last verified
- Jan 2023
- First submitted
- 17 Dec 2019
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Subject information and biological samples will be used and shared with the researchers involved in this study to conduct the research.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Precision Sleep Ventilation (PSV) Chronic Respiratory Failure Management Program for Patients With Advanced Hypercapnic COPD
- ClinicalTrials.gov ID
- NCT04210050
- Acronym / sponsor ID
- 2019P000778
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was not initiated due to COVID19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Breas Medical S.A.R.L.
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Dec 2019 (actual)
- 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.
Despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of COPD patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. There is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous CO2 tracking.
The driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic COPD.
Detailed description
The purpose of this protocol is to perform a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure. The study will focus on the primary end-points of time to hospital re-admission for acute exacerbation of COPD and/or an episode of acute on chronic hypercapnic respiratory failure, in addition to other clinically relevant outcomes including patient health-related quality of life, sleep quality indices, and gas exchange parameters. Approximately 300 BIDMC adult patients will be recruited and each patient monitored over a period of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The model is a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult COPD patients with chronic hypercapnic respiratory failure.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Other | Diagnostic Test: Arterial blood gas (ABG) and serum bicarbonate level, Diagnostic Test: Overnight home oximetry and transcutaneous CO2 monitoringUsual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. |
| Usual care plus NIPPV group only | Active comparator | Device: Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical., Diagnostic Test: Arterial blood gas (ABG) and serum bicarbonate level, Diagnostic Test: Overnight home oximetry and transcutaneous CO2 monitoringUsual care for COPD based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines plus use of nocturnal ventilator device using the Breas VIVO 50 home ventilator, Breas Medical (or any newer models as available). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent prior to any study-mandated procedure.
- Male or female aged ≥ 18 years with advanced hypercapnic COPD
- Willingness to use NIPPV treatment
- English speaking
- Women and minorities will be recruited in numbers reflecting representation in the Boston Metropolitan community which is approximately 84% Caucasian, 9% African American, 5% Hispanic American, and 2% Asian American, as the knowledge gained can apply to individuals of all ethnic background and gender.
Key exclusion criteria (14 listed)
- Significant sleep disordered breathing (AHI 4% ≥ 15 events/hour) or high clinical suspicion (BMI ≥ 35)
- Neuromuscular disease or other causes of hypoventilation
- Abnormalities of the thorax or lungs other than COPD
- Already treated with home NIPPV
- Unable to wean from ventilator during admission
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 |
|---|---|---|
| Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.In the usual care plus NIPPV group, those able to undergo attended PSG will be titrated with volume targeted pressure support mode, aiming to lower the baseline TcCO2 by 10 mmHg. In some cases, the CO2 cannot be lowered by that amount on a single titration, but rather will decrease over time. For those unable to undergo lab titration (too frail, no transportation, decline/refuse), NIPPV will be initiated with empiric settings based on nighttime home CO2 tracking and daytime ABG monitoring. | Device | Usual care plus NIPPV group only |
| Arterial blood gas (ABG) and serum bicarbonate levelWill be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study | Diagnostic test | Usual care, Usual care plus NIPPV group only |
| Overnight home oximetry and transcutaneous CO2 monitoringwill be conducted at 1 and 6 months into the study (for subjects in the NIPPV plus usual care group, testing will be done while using the ventilator. | Diagnostic test | Usual care, Usual care plus NIPPV group only |
Primary outcome
Time to readmission or death
Time frame: within 12 months
time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death
4 secondary outcomes
Patient health related quality of life (HRQOL)
Time frame: 12 months
Dyspnea scale
Time frame: 12 months
Gas exchange
Time frame: 12 months
General health status
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Undecided. Subject information and biological samples will be used and shared with the researchers involved in this study to conduct the research.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical., Arterial blood gas (ABG) and serum bicarbonate level and Overnight home oximetry and transcutaneous CO2 monitoring in people with COPD, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Time to readmission or death (time frame: within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2023.