Clinical trial NCT04210050: Sleep Ventilation for Patients With Advanced Hypercapnic COPD
Official title: Implementation of a Precision Sleep Ventilation (PSV) Chronic Respiratory Failure Management Program for Patients With Advanced Hypercapnic COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COPD
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Breas Medical S.A.R.L.
First posted: 2019-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to any study-mandated procedure.
2. Male or female aged ≥ 18 years with advanced hypercapnic COPD

   1. FEV1 ≤ 50% predicted and
   2. 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
3. Willingness to use NIPPV treatment
4. 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

Primary outcomes:
measure: Time to readmission or death
timeFrame: within 12 months
Secondary outcomes:
measure: Patient health related quality of life (HRQOL)
timeFrame: 12 months
measure: Dyspnea scale
timeFrame: 12 months
measure: Gas exchange
timeFrame: 12 months
measure: General health status
timeFrame: 12 months
Other outcomes:
measure: Ambulatory BP profiles
timeFrame: 3 months compared to baseline
measure: Inflammatory biomarkers
timeFrame: 3 and 12 months compared to baseline
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: