- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210050
Sleep Ventilation for Patients With Advanced Hypercapnic COPD
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Usual care
Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
|
Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study
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.
|
Active Comparator: Usual care plus NIPPV group only
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).
|
Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
within 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient health related quality of life (HRQOL)
Time Frame: 12 months
|
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. |
12 months
|
Dyspnea scale
Time Frame: 12 months
|
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.
|
12 months
|
Gas exchange
Time Frame: 12 months
|
Change in CO2 from ABG and serum bicarbonate
|
12 months
|
General health status
Time Frame: 12 months
|
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).
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ambulatory BP profiles
Time Frame: 3 months compared to baseline
|
In a subset of subjects (from usual care and usual care plus ventilation groups), 24-hour ambulatory BP monitoring will be conducted (at baseline and after 3 months) to assess for change in 24-hour and nocturnal systolic, diastolic and mean BPs.
|
3 months compared to baseline
|
Inflammatory biomarkers
Time Frame: 3 and 12 months compared to baseline
|
High sensitivity C-reactive protein [hs-CRP], units mg/ml, can be measured from peripheral blood.
Elevated levels reflect increased systemic inflammation.
Studies have shown that individuals with elevated levels (above 2 mg/ml) are at increased risk of cardiovascular disease.
During this trial, HR-CRP will be obtained at baseline and after 3 and 12 months in subjects to assess whether there is a favorable change in subjects treated with nocturnal ventilation + usual care, as compared to usual care.
|
3 and 12 months compared to baseline
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P000778
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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