NIV for COPD: Hospital to Home (H2H)
Pulmonary Disease, Chronic Obstructive, Noninvasive Ventilation
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD, BIPAP, NIV, Respiratory failure
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- San Francisco VA Health Care System
Arms of the Study
Arm 1
Experimental
Noninvasive Ventilation
Subjects will be introduced to NIV and educated on sleep disordered breathing. NIV will be initiated during hospitalization following resolution of acute respiratory failure. NIV settings will be based on inspiratory and expiratory positive airway pressures (IPAP, EPAP), rates, and tidal volumes tolerated during the acute phase of treatment. Initial settings will be set with goals of tolerance and acceptance of therapy. Minimum pressure difference between IPAP and EPAP settings will be 5cmH20. Volume assured pressure support mode with a target tidal volume (Vt) of 8ml/kg ideal body weight will be used. Final device settings and patient parameters will be documented after 10 minutes of acclimation to the device. Data from the device will be reviewed the following day. Tolerance, mask comfort, and acceptance of therapy will be assessed. Changes to settings, mask interface, or other comfort features will be performed at this initial reassessment period.