Real-world telemonitoring and remote support for home non-invasive ventilation to improve therapy effectiveness: the exploratory, multicentre randomised eVENT study.

A French national telemonitoring programme incorporating remote support and therapeutic education is designed to improve patient pathways and reduce healthcare resource utilisation.

一个包含远程支持和治疗教育的法国国家远程监控计划被设计出来，旨在改善患者路径并减少医疗资源的使用。

This study investigated the impact of the telemonitoring programme versus usual follow-up on the effectiveness of home NIV.

本研究调查了远程监测计划与常规随访相比对家庭无创通气(NIV)效果的影响。

Methods

The prospective, multicentre, open-label eVENT trial enrolled adults recently started on home NIV.

前瞻性、多中心、开放标签的eVENT试验招募了最近开始家庭NIV治疗的成年人。

Participants were randomised to the telemonitoring or usual follow-up group.

参与者被随机分配到远程监测组或常规随访组。

In the telemonitoring group, a CE-marked algorithm generated alerts based on teletransmitted ventilator data.

在远程监测组中，一个带有CE标志的算法根据远程传输的呼吸机数据生成警报。

Specialised nurses managed alerts and provided therapeutic education.

专业护士管理警报并提供治疗教育。

The primary outcome was mean nocturnal transcutaneous carbon dioxide level (PtCO2) on NIV after 6 months.

主要结果是在使用NIV（无创通气）6个月后的夜间平均经皮二氧化碳水平（PtCO2）。

Results

56 patients were randomised and 53 were analysed (telemonitoring: n=27, usual follow-up: n=26).

共有56名患者被随机分配，其中53名患者被纳入分析（远程监测组：n=27，常规随访组：n=26）。

At 6 months, mean PtCO2 did not differ significantly between the telemonitoring and usual follow-up groups (42.1±6.1 vs 43.9±6.4 mm Hg; p=0.352) but mean room air partial arterial carbon dioxide pressure (PaCO2) was significantly lower in the telemonitoring versus usual follow-up group (41.7±6.8 vs 46.2±3.5 mm Hg; p=0.003).

在6个月时，远程监测组与常规随访组的平均PtCO2没有显著差异（42.1±6.1 vs 43.9±6.4毫米汞柱；p=0.352），但远程监测组的平均室内空气部分动脉二氧化碳压（PaCO2）显著低于常规随访组（41.7±6.8 vs 46.2±3.5毫米汞柱；p=0.003）。

The proportion of participants without diurnal or nocturnal hypercapnia at 6 months was 82.6% with telemonitoring and 27.3% with usual follow-up (p<0.001).

6个月时，没有日间或夜间高碳酸血症的参与者比例在远程监测组为82.6%，而在常规随访组为27.3%（p<0.001）。

Compared with usual follow-up, the telemonitoring group had greater NIV use, more days with NIV usage ≥4 hour and less non-intentional leaks.

与常规随访相比，远程监测组的NIV使用更多，NIV使用天数≥4小时的天数更多，非故意漏气更少。

Conclusions

In patients on home NIV, PtCO2 was similar with telemonitoring and usual follow-up, but PaCO2 levels and the quality of ventilatory support were significantly better with telemonitoring.

在使用家庭无创通气(NIV)的患者中，通过远程监测和常规随访的经皮二氧化碳分压(PtCO2)相似，但动脉二氧化碳分压(PaCO2)水平和通气支持的质量在远程监测下显著更好。

trial_registration_number

NCT04615078.

NCT04615078。