真实环境多中心研究中适应性伺服通气设置模式:注意容量!:真实条件下的适应性伺服通气设置。

Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions.

机构信息

Department of Respiratory Diseases, Univ Montpellier, CHU Montpellier, 371, Avenue Doyen Giraud, 34295, Montpellier Cedex 5, France.

PhyMedExp, Univ Montpellier, CNRS, INSERM, CHU Montpellier, Montpellier, France.

出版信息

Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.

Abstract

BACKGROUNDS

To explain the excess cardiovascular mortality observed in the SERVE-HF study, it was hypothesized that the high-pressure ASV default settings used lead to inappropriate ventilation, cascading negative consequences (i.e. not only pro-arrythmogenic effects through metabolic/electrolyte abnormalities, but also lower cardiac output). The aims of this study are: i) to describe ASV-settings for long-term ASV-populations in real-life conditions; ii) to describe the associated minute-ventilations (MV) and therapeutic pressures for servo-controlled-flow versus servo-controlled-volume devices (ASV-F Philips®-devices versus ASV-V ResMed®-devices).

METHODS

The OTRLASV-study is a cross-sectional, 5-centre study including patients who underwent ASV-treatment for at least 1 year. The eight participating clinicians were free to adjust ASV settings, which were compared among i) initial diagnosed sleep-disordered-breathing (SBD) groups (Obstructive-Sleep-Apnea (OSA), Central-Sleep-Apnea (CSA), Treatment-Emergent-Central-Sleep-Apnea (TECSA)), and ii) unsupervised groups (k-means clusters). To generate these clusters, baseline and follow-up variables were used (age, sex, body mass index (BMI), initial diagnosed Obstructive-Apnea-Index, initial diagnosed Central-Apnea-Index, Continuous-Positive-Airway-Pressure used before ASV treatment, presence of cardiopathy, and presence of a reduced left-ventricular-ejection-fraction (LVEF)). ASV-data were collected using the manufacturer's software for 6 months.

RESULTS

One hundred seventy-seven patients (87.57% male) were analysed with a median (IQ) initial Apnea-Hypopnea-Index of 50 (38-62)/h, an ASV-treatment duration of 2.88 (1.76-4.96) years, 61.58% treated with an ASV-V. SDB groups did not differ in ASV settings, MV or therapeutic pressures. In contrast, the five generated k-means clusters did (generally described as follows: (C1) male-TECSA-cardiopathy, (C2) male-mostly-CSA-cardiopathy, (C3) male-mostly-TECSA-no cardiopathy, (C4) female-mostly-elevated BMI-TECSA-cardiopathy, (C5) male-mostly-OSA-low-LVEF). Of note, the male-mostly-OSA-low-LVEF-cluster-5 had significantly lower fixed end-expiratory-airway-pressure (EPAP) settings versus C1 (p = 0.029) and C4 (p = 0.007). Auto-EPAP usage was higher in the male-mostly-TECSA-no cardiopathy-cluster-3 versus C1 (p = 0.006) and C2 (p < 0.001). MV differences between ASV-F (p = 0.002) and ASV-V (p < 0.001) were not homogenously distributed across clusters, suggesting specific cluster and ASV-algorithm interactions. Individual ASV-data suggest that the hyperventilation risk is not related to the cluster nor the ASV-monitoring type.

CONCLUSIONS

Real-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful. At the patient level, a hyperventilation risk exists regardless of cluster or ASV-monitoring type, spotlighting a future role of MV-telemonitoring in the interest of patient-safety.

TRIAL REGISTRATION

The OTRLASV study was registered on ClinicalTrials.gov (Identifier: NCT02429986 ). 1 April 2015.

摘要

背景

为了解释 SERVE-HF 研究中观察到的心血管死亡率过高的现象,有人假设使用的高压力 ASV 默认设置会导致通气不当,从而产生一系列负面后果(即不仅通过代谢/电解质异常导致致心律失常作用,而且还会降低心输出量)。本研究的目的是:i)描述真实环境中长期接受 ASV 治疗的人群的 ASV 设置;ii)描述与伺服控制流量和伺服控制容量设备(ASV-F Philips®设备与 ASV-V ResMed®设备)相关的分钟通气量(MV)和治疗压力。

方法

OTRLASV 研究是一项横断面、五中心研究,包括至少接受 1 年 ASV 治疗的患者。八名参与的临床医生可以自由调整 ASV 设置,将其在 i)初始诊断为睡眠呼吸障碍(SBD)的组(阻塞性睡眠呼吸暂停(OSA)、中枢性睡眠呼吸暂停(CSA)、治疗后出现的中枢性睡眠呼吸暂停(TECSA))和 ii)未受监督的组(k-均值聚类)之间进行比较。为了生成这些聚类,使用了基线和随访变量(年龄、性别、体重指数(BMI)、初始诊断的阻塞性呼吸暂停指数、初始诊断的中枢性呼吸暂停指数、使用的持续气道正压(CPAP)治疗前的 ASV 治疗、心脏病和左心室射血分数降低(LVEF)的存在)。使用制造商的软件收集了 6 个月的 ASV 数据。

结果

对 177 名(87.57%为男性)患者进行了分析,中位(IQ)初始呼吸暂停低通气指数为 50(38-62)/小时,ASV 治疗持续时间为 2.88(1.76-4.96)年,61.58%接受 ASV-V 治疗。SBD 组的 ASV 设置、MV 或治疗压力没有差异。相比之下,生成的五个 k-均值聚类确实存在差异(一般描述如下:C1 为男性-TECSA-心脏病,C2 为男性-主要为 CSA-心脏病,C3 为男性-主要为 TECSA-无心脏病,C4 为女性-主要为升高的 BMI-TECSA-心脏病,C5 为男性-主要为 OSA-低 LVEF)。值得注意的是,男性-主要为 OSA-低 LVEF 聚类-5 的固定呼气末气道压力(EPAP)设定值明显低于 C1(p=0.029)和 C4(p=0.007)。男性-主要为 TECSA-无心脏病聚类-3 的自动 EPAP 使用量高于 C1(p=0.006)和 C2(p<0.001)。ASV-F(p=0.002)和 ASV-V(p<0.001)之间的 MV 差异在聚类之间分布不均匀,表明存在特定的聚类和 ASV 算法相互作用。个别 ASV 数据表明,过度通气风险与聚类或 ASV 监测类型无关。

结论

真实生活中的 ASV 设置与基线和随访变量的组合相关,其中心血管变量仍然具有临床意义。在患者层面上,无论聚类或 ASV 监测类型如何,都存在过度通气的风险,这突显了 MV 远程监测在患者安全方面的未来作用。

试验注册

OTRLASV 研究在 ClinicalTrials.gov 上注册(标识符:NCT02429986)。2015 年 4 月 1 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/73af/7507637/633c19c4d9f5/12931_2020_1509_Fig1_HTML.jpg

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