Status:
TERMINATED
NIV for COPD: Hospital to Home
Lead Sponsor:
San Francisco Veterans Affairs Medical Center
Collaborating Sponsors:
ResMed
Conditions:
Pulmonary Disease, Chronic Obstructive
Noninvasive Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot study to evaluate the impact of providing patients admitted with acute exacerbations of COPD (AECOPD) with non-invasive ventilation (NIV)home devices prior to discharge on hospital rea...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, with the economic and social burden of disease anticipated to increase annually. Acute exacerbatio...
Eligibility Criteria
Inclusion
- Admission for acute hypercapnic respiratory failure requiring mechanical ventilation or NIV
- Resolution of acute respiratory failure reflected by normalization of pH and downgrade of clinical status to ward or floor status.
- Severe COPD defined by GOLD stage 3 (FEV1 30-50%) or 4 (FEV1 \< 30%) OR GOLD C or D. Pulmonary function tests (PFTs) done within 3 years preceding admission are acceptable to document an obstructive ventilatory defect and decrease diffusion capacity consistent with emphysema and COPD. If no PFTs are available, bedside spirometry will be performed to confirm COPD.
- Chronic compensated respiratory acidosis based on PaCO2 \>52 adjusted for pH 7.40, on pre-admission laboratory values or after resolution of acute respiratory failure.
- Able to consent without surrogate and complete all required study visits.
Exclusion
- Moderate or severe obstructive sleep apnea (OSA), apnea-hypopnea index (AHI) \>15/h. Sleep testing done within the prior 3 years with no increase in body mass index (BMI) \>2kg/m2 or major change in cardiopulmonary conditions (new reduced ejection heart failure \[HFrEF\], atrial fibrillation \[AFib\], opioid use with morphine dose equivalent (MDDE) \>120mg, or cardiothoracic surgery for lung resection or coronary artery bypass grafting) will be accepted for AHI severity.
- BMI\>35 kg/m2
- Congestive heart failure (HFrEF, EF\< 45%)
- Other cause of chronic respiratory failure: Obesity hypoventilation syndrome, spinal cord injury (cervical or thoracic) neuromuscular disease, diaphragmatic paralysis, chest wall restrictive ventilatory defect
- Lack of stable housing, homelessness, or unreliable electricity source in home environment.
- Use of NIV at home within past three months
- Failure to tolerate NIV during initial hospitalization
- Unable or unwilling to comply with the protocol
- Age \<18 years
- Inability to consent due to limited cognitive capacity
- Pregnancy
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04413643
Start Date
May 9 2019
End Date
April 1 2024
Last Update
April 25 2024
Active Locations (1)
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1
San Francisco VA Health Care System
San Francisco, California, United States, 94121