Nocturnal oxygenation in patients on long-term oxygen therapy Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged over 18 years on chronic domiciliary oxygen therapy
Exclusion criteria
Exclusion criteria: 1. Requiring >6 L of O2 per minute at baseline 2. Previously established need for any nocturnal positive airway pressure therapy for conditions such as CPAP for obstructive sleep apnea (OSA), ASV for central sleep apnea, or BiPAP for obesity hypoventilation syndrome 3. Patients fully dependent on mechanical ventilation and/or those with facial injuries that preclude the use of a standard cannula or the PPNC will be excluded 4. Patients with an Apnea-Hypopnea Index (AHI) >15 will be excluded from further testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nocturnal average SpO2 by pulse oximetry, measured at baseline with a standard cannula + stationary concentrator compared to a PillowsPlus nasal cannula + a portable concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. Designed and powered for non-inferiority. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nocturnal average heart rate by pulse oximetry, measured at baseline with a standard cannula +stationary concentrator compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. 2. Frequency of oxygen desaturation events of 3% or greater by pulse oximetry, measured by blinded, manual scoring of oximetry data by a respirologist. Baseline recorded with standard cannula +stationary concentrator, compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. 3. Patient comfort data as measured with patient surveys at baseline with standard cannula +stationary concentrator, compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. | — |
Countries
Canada