Krogh Jesper, Plomgaard Peter, Frikke-Schmidt Ruth, Velschow Sten, Johannesen Jesper, Hilsted Linda Maria, Schrøder Malene, Feldt-Rasmussen Ulla
Department of Endocrinology & Metabolism, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Endocr Connect. 2023 Jun 8;12(7). doi: 10.1530/EC-23-0087. Print 2023 Jul 1.
Repeated blood sampling is required in certain clinical and research settings, which is currently performed by drawing blood from venous catheters requiring manual handling of each sample at the time of collection. A novel body-worn device for repeated serial samples, Fluispotter®, with automated extraction, collection, and storage of up to 20 venous dried blood spot samples over the course of 20 h may overcome problems with current methods for serial sampling. The purpose of this study was to assess the performance and safety of Fluispotter for the first time in healthy subjects. Fluispotter consists of a cartridge with tubing, a reservoir for flushing solution, pumps and filterpaper, and a multi-lumen catheter placed in the brachial vein. We recruited healthy subjects for testing in an in-hospital setting. Fluispotter was attached by an anesthesiologist to 22 healthy subjects of which 9/22 (40.9%) participants had all 20 samples taken, which was lower than the goal of complete sampling in 80% of the subjects (P = 0.02). The main reason for sample failure was clogging of blood flow which was observed in 11/22 (50%) of the participants. No serious adverse events occurred, and the participants rated the pain from the insertion and the removal of catheter as very low. A cortisol profile showed nadir values at midnight and highest values at 05:00 h. Although full sampling was not successful in all participants, the Fluispotter technology proved safe and highly acceptable to the participants producing the expected cortisol profile without the requirement of staff during sample collection.
在某些临床和研究环境中需要重复采血，目前是通过从静脉导管采血来进行，在采集时需要人工处理每个样本。一种用于重复采集系列样本的新型可穿戴设备Fluispotter®，能够在20小时内自动提取、收集和存储多达20个静脉干血斑样本，可能会克服当前系列采样方法存在的问题。本研究的目的是首次在健康受试者中评估Fluispotter的性能和安全性。Fluispotter由一个带有 tubing的药筒、一个冲洗溶液储存器、泵和滤纸，以及一根置于肱静脉的多腔导管组成。我们招募健康受试者在医院环境中进行测试。一名麻醉师将Fluispotter连接到22名健康受试者身上，其中9/22（40.9%）的参与者采集了全部20个样本，低于80%的受试者完成采样的目标（P = 0.02）。样本采集失败的主要原因是血流堵塞，在11/22（50%）的参与者中观察到这一情况。未发生严重不良事件，参与者对导管插入和拔除时的疼痛评分很低。皮质醇曲线显示午夜时最低值，05:00时最高值。尽管并非所有参与者都成功完成了全部采样，但Fluispotter技术被证明是安全的，并且受试者高度接受，在样本采集过程中无需工作人员参与即可产生预期的皮质醇曲线。
