Sleep Ventilation for Patients With Advanced Hypercapnic COPD

NCT ID: NCT04210050

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2026-07-31

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

Usual care follows the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.

Group Type: OTHER

Arterial blood gas (ABG) and serum bicarbonate level

Intervention Type: DIAGNOSTIC_TEST

Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study

Overnight home oximetry and transcutaneous CO2 monitoring

Intervention Type: DIAGNOSTIC_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.

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).

Group Type: ACTIVE_COMPARATOR

Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.

Intervention Type: 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 level

Intervention Type: DIAGNOSTIC_TEST

Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study

Overnight home oximetry and transcutaneous CO2 monitoring

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DEVICE

Arterial blood gas (ABG) and serum bicarbonate level

Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study

Intervention Type: DIAGNOSTIC_TEST

Overnight home oximetry and transcutaneous CO2 monitoring

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Breas Medical S.A.R.L.

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019P000778

Identifier Type: -

Identifier Source: org_study_id