Sleep Ventilation for Patients With Advanced Hypercapnic COPD

NCT04210050 | Withdrawn FDA Device

• 1 other identifier: 2019P000778
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Time to readmission or death

  time to re-admission for acute exacerbation of COPD and/or acute on chronic hypercapnic respiratory failure or death

  within 12 months

Secondary Outcomes (4)

• Patient health related quality of life (HRQOL)

  12 months

• Dyspnea scale

  12 months

• Gas exchange

  12 months

• General health status

  12 months

Other Outcomes (2)

• Ambulatory BP profiles

  3 months compared to baseline

• Inflammatory biomarkers

  3 and 12 months compared to baseline

Study Arms (2)

Usual care

OTHER

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

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).

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

Interventions

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.

Usual care plus NIPPV group only

Arterial blood gas (ABG) and serum bicarbonate level DIAGNOSTIC_TEST

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

Usual care; Usual care plus NIPPV group only

Overnight home oximetry and transcutaneous CO2 monitoring 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; Usual care plus NIPPV group only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Breas Medical S.A.R.L.: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 24, 2019
• Study Start: September 30, 2020
• Primary Completion: January 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

US (1)