Background: Leakage is common in patients receiving home mechanical ventilation (HMV) via a face mask. Although pressure ventilators have partial compensatory capacity, excessive leakage can compromise the effectiveness of treatment. Home ventilators are equipped with built-in software which provides information on leakage. However, the values of leakage and their effects in routine clinical practice are currently little known. Objective: To measure leakage in stable patients on nocturnal HMV and its impact on treatment effectiveness. Methods: Consecutive outpatients on HMV were recruited. Nocturnal pulse oximetry was performed at home and leakage was measured using the ventilator’s built-in software. We measured: mean SpO₂, percentage of time with SpO₂ <90% (T90), mean leakage (meanL), maximum leakage (maxL), and minimum leakage (minL) during the ventilation session. We estimated ventilator capacity to compensate for leakage according to inspiratory positive airway pressure and divided the patients into two groups: those with leak compensation and those without. Results: The study included 41 patients [mean age, 64 years (SD 11.9); 23 (56%) women]. Nocturnal pulse oximetry showed an SpO₂ of 94% (±2.9) and a T90 of 10% (±21.7). Leakage (in l/min) was: meanL, 32.2 (±15.3); maxL, 64.8 (±28.5), and minL, 18.8 (±10.6). Seven cases (17%) had leakage greater than the ventilator compensatory capacity, but no significant difference in SpO₂ or T90 was observed between patients with or without leak compensation. Conclusions: A wide variation between maxL and minL was observed in our series; 17% of cases had higher leakage values than the compensatory capacity of the ventilator, but this did not affect nocturnal oxygenation.

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Chronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death worldwide by 2020. Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death. Recent studies suggested that NIV at home can reduce readmissions, but in a small proportion of patients, and with a high level of expertise. Other studies, however, do not show any benefit of home NIV. This could be related to the fact that respiratory failure in patients with stable COPD and their response to mechanical ventilation are influenced by several pathophysiological factors which frequently coexist in the same patient to varying degrees. These pathophysiological factors might influence the success of home NIV in stable COPD, thus long-term NIV specifically adapted to a patient’s “phenotype” is likely to improve prognosis, reduce readmission to hospital, and prevent death. In view of this conundrum, Rescue2-monitor (R2M), an open-label, prospective randomized, controlled study performed in patients with hypercapnic COPD post-AHRF, will investigate the impact of the quality of nocturnal NIV on the readmission-free survival. The primary objective is to show that any of 3 home NIV strategies (“rescue,” “non-targeted,” and “targeted”) will improve readmission-free survival in comparison to no-home NIV. The “targeted” group of patients will receive a treatment with personalized (targeted) ventilation settings and extensive monitoring. Furthermore, the influence of comorbidities typical for COPD patients, such as cardiac insufficiency, OSA, or associated asthma, on ventilation outcomes will be taken into consideration and reasons for non-inclusion of patients will be recorded in order to evaluate the percentage of ventilated COPD patients that are screening failures. ClinicalTrials.gov NCT03890224. Registered on March 26, 2019.