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Randomized trial evaluates nocturnal oxygenation and comfort in long-term oxygen therapy users, indicating potential benefits of a novel cannula.
Rationale Long-term oxygen therapy (LTOT) improves survival in chronic lung disease, but portable oxygen delivery can be limited by unreliable breath detection and nasal irritation from standard cannulas. The PillowsPlus Nasal Cannula (PPNC) (figure 1) was designed to enhance triggering efficiency of pulsed-flow oxygen systems and reduce discomfort. This study evaluated safety, nocturnal oxygenation, and comfort/usability of the PPNC compared with current standard nasal cannula. Methods Participants had COPD, interstitial lung disease, or pulmonary hypertension, with mean age 68±9 years and 54% male. Patients with oxygen requirements of more than 6 litres/min were excluded. On consecutive nights, patients used: (1) standard cannula with continuous-flow concentrator (baseline standard of care), (2) PPNC with continuous-flow concentrator, and (3) PPNC with pulsed-flow concentrator. SpO2 and heart rate were continuously monitored. Patients with 10 or more oxygen desaturation events per hour (ODI - defined at a 3% drop) on night 1 completed the series and were included in fit/comfort data, but excluded from SpO2 and heart rate analysis due to confounding sleep-breathing issues. Randomization for the order of nights 2 and 3, provided blinding for data analysis. Clinical non-inferiority was defined as nocturnal SpO2 within 4% of baseline. Results 27 patients were recruited, with 24 completing the full trial. No patients were excluded due to ODI >10. The mean change in nocturnal SpO2 of PPNC with pulsed-flow vs. standard cannula with continuous-flow was -1.55 ± 0.75%, remaining clearly within the non-inferiority margin; only one patient had a decline >4%. No significant heart rate differences were observed (p ≥ 0.940). Comfort survey data (n = 24) revealed slightly higher perceived breathing resistance with PPNC (2.2/5 vs. 1.5/5) but less nasal dryness (2.6/5 vs. 3.3/5). Fit ratings were higher with PPNC (4.1/5 vs. 3.6/5), though 17% reported poor fit due to single-size availability. Position retention was similar (3.7/5 vs. 3.8/5). Eleven patients rated PPNC more comfortable, 12 reported improved sleep. Conclusions The PPNC maintained safe nocturnal oxygenation during both continuous and pulsed-flow use, with SpO2 levels using pulsed-flow that met non-inferiority criteria. Survey data suggest improvements in dryness and overall comfort, with acceptable fit and positioning despite the use of a single size for all patients. Over half of participants reported willingness to adopt the PPNC. These findings support the PPNC as a versatile nasal interface to enhance portability, reliability, and quality of life in LTOT users.
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Vis et al. (2026) studied this question.
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