Overnight Oxygenation and Patient Comfort Using a New Nasal Cannula Versus Standard Cannula in Long-Term Oxygen...

Long-term oxygen therapy (LTOT) improves survival in chronic lung disease, but portable oxygen delivery can be limited by unreliable breath detection from standard cannulas. The investigational cannula (PillowsPlus Nasal Cannula) was designed to enhance triggering efficiency of pulsed-flow oxygen sources while maintaining comfort. This study evaluated safety, nocturnal oxygenation, and comfort of the investigational cannula compared with a standard nasal cannula.

Participants on LTOT of ≤6 L/min were recruited. On consecutive nights, participants used: (1) standard cannula with continuous-flow concentrator (baseline standard of care), (2) investigational cannula with continuous-flow concentrator, and (3) investigational cannula with pulsed-flow concentrator. $S_{{\mathrm{pO}}_2}$ and heart rate were continuously monitored. The order of nights 2 and 3 was randomized to provide blinding for data analysis. The primary outcome was mean $S_{{\mathrm{pO}}_2}$ under each condition. Clinical non-inferiority was defined as nocturnal $S_{{\mathrm{pO}}_2}$ within 4% of baseline.

Twenty-seven LTOT users were recruited, with 24 completing the full trial. Median age was 69.5 (IQR 66.5-73.5) years and 37.5% were male. The mean change in nocturnal $S_{{\mathrm{pO}}_2}$ for investigational cannula with pulsed-flow versus standard cannula with continuous-flow was -1.55 ± 0.75%, remaining within the non-inferiority margin. The mean $S_{{\mathrm{pO}}_2}$ with the investigational cannula in with continuous flow was virtually identical to the standard cannula (difference < 0.1%). No significant heart rate differences were observed. Comfort survey data (N = 24) indicated that ratings for nasal dryness, fit, position retention, and sleep quality were statistically similar between devices.

The investigational cannula maintained safe nocturnal oxygenation during both continuous and pulsed-flow use, as $S_{{\mathrm{pO}}_2}$ levels during both conditions met non-inferiority criteria. Survey data suggest acceptable comfort, fit, and positioning. Over half of participants reported willingness to adopt the investigational cannula. These findings support the investigational cannula as a well-tolerated new nasal interface.