Sleep Ventilation for Patients With Advanced Hypercapnic COPD

Not Applicable

Withdrawn

• Conditions: COPD
• Interventions: 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

• Registration Number: NCT04210050
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Study Start: 2020-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2025-01
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care plus NIPPV group only	Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.	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).
Usual care	Arterial blood gas (ABG) and serum bicarbonate level	Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Usual care plus NIPPV group only	Arterial blood gas (ABG) and serum bicarbonate level	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).
Usual care	Overnight home oximetry and transcutaneous CO2 monitoring	Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Usual care plus NIPPV group only	Overnight home oximetry and transcutaneous CO2 monitoring	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).

Primary Outcome Measures

Name	Time	Method
Time to readmission or death	within 12 months	time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death

Secondary Outcome Measures

Name	Time	Method
Patient health related quality of life (HRQOL)	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.
Dyspnea scale	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.
Gas exchange	12 months	Change in CO2 from ABG and serum bicarbonate
General health status	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).

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States