Impact of Unintentional Air Leaks on Automatic Positive Airway Pressure Device Performance in Simulated Sleep Apnea Events

Abstract

BACKGROUND: Positive airway pressure (PAP) is the accepted standard treatment for obstructive sleep apnea. In the last decades, automatic PAP (APAP) adjustment modes have been increasingly used. Pressure auto adjustment offers better comfort to the patient and represents a valuable help for the clinician to provide optimal treatment. However, device performance differs among manufacturers. Furthermore, the success of the therapy relies greatly on unintentional air leak (UAL) level for many reasons, hence the importance to investigate the performance of the most common devices. The aim of this study was to compare the performance of 3 APAP devices from the most common manufacturers in specific conditions (obstructive sleep apnea, central sleep apnea, hypopnea), with and without UAL. METHODS: This was a bench test study. Performance tests were conducted on a breathing simulator using a Starling resistor, representing the upper airways, and an adjustable UAL valve. Three APAP devices (AirSense 10, DreamStation, and Prisma 20A) were tested in different scenarios. RESULTS: Without UAL, performance of the 3 devices was similar to existing literature. However, performance was altered with the addition of UAL in some scenario. The AirSense 10 was not able to respond correctly to obstructive apnea (intraclass correlation coefficient [ICC] 0.021, P 5 .61) and hypopnea (ICC 0.059, P 5 .26). Prisma 20A lowest performance was seen during simulated obstructive apnea (ICC 0.708, P < .001). DreamStation lowest performance was seen during simulated hypopnea events (ICC 0.755, P < .001). CONCLUSIONS: All 3 APAP devices reacted differently to the added UAL. Performance was altered with some devices, which could affect the therapy success in patients with sleep apnea syndrome. The variability of performance of some APAP devices with UAL should make clinicians evaluate their use in a home setting.

Ventilators, Settings, Autotitration Algorithms

“…The four ventilators, with different upper airway patency determination algorithms, showed different performances under the simulated conditions [46]. The concomitant presence of unintentional leakage may also contribute to undesired responses of auto-EPAP algorithms [47].…”

Sleep well with home automation

“…Unintentional leak is an important factor with respect to CPAP acceptance and adherence, impact on accuracy of event determination and adequacy of treatment, particularly in APAP mode. 10 However, a few trials have compared leak between APAP and fixed CPAP, finding no significant differences, and that leak mainly depended on mean pressure and interface type. 11 This study also withdrew patients with excessive leak, which would have affected the applicability of the data to the proportion of patients who require more attention to mask-fitting.…”

“…It would have been useful to compare differences between the two modes of CPAP and whether they correlated with the differences in the CPAP tolerance questionnaire, such as nasal complaints and dry mouth. Unintentional leak is an important factor with respect to CPAP acceptance and adherence, impact on accuracy of event determination and adequacy of treatment, particularly in APAP mode 10 . However, a few trials have compared leak between APAP and fixed CPAP, finding no significant differences, and that leak mainly depended on mean pressure and interface type 11 .…”