Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
VIPUN Medical, Mechelen, Belgium.
Neurogastroenterol Motil. 2024 Jun;36(6):e14783. doi: 10.1111/nmo.14783. Epub 2024 Mar 15.
Gastrointestinal dysmotility is frequently suspected in patients with gastroparesis, functional dyspepsia, and ileus, and in the intensive care unit. Monitoring of gastric motility in clinical practice remains challenging. A novel technology was developed to meet the medical need for a widely available bedside tool to monitor gastric motility continuously. The VIPUN™ Gastric Monitoring System (GMS) comprises a nasogastric feeding tube with intragastric balloon to allow for measuring gastric contractions.
To compare the performance of the VIPUN GMS versus a reference technique (manometry).
In this validation study in healthy subjects, the investigational catheter and a solid-state manometry catheter were placed in the stomach concomitantly. Motility was recorded for 2.5 h: 2 h in a fasting state, followed by a 400-kcal liquid meal, and monitoring of the fed state for the remaining half hour. The performance of both systems was compared by automated recognition and manual identification of the contractile activity. Data are presented as mean (standard deviation).
The analysis set comprised 13 healthy subjects (6 women, age: 27.5 (8.1) years, BMI: 22.2 (2.46) kg/m). Automatically-recognized contractility was strongly correlated between the two techniques (endpoint: contraction duration; Spearman ρ = 0.96, p < 0.001). A correlation was also observed between the number of individual contractions identified by expert gastroenterologists on both technologies independently (ρ = 0.71, p = .007) and between the contractions identified by the experts and by the GMS software (ρ = 0.87, p = 0.001). No serious or unanticipated adverse events occurred.
CONCLUSIONS & INFERENCES: The observed strong correlations with the gold standard, manometry, validate the performance of the VIPUN GMS as a gastric monitoring system.
胃动力障碍常发生于胃轻瘫、功能性消化不良和肠梗阻患者以及重症监护病房（ICU）中。在临床实践中，胃动力监测仍然具有挑战性。为满足广泛应用于床边监测胃动力的需求，开发了一种新技术。VIPUN™胃动力监测系统（GMS）由带有胃内球囊的鼻胃管组成，用于测量胃收缩。
比较 VIPUN GMS 与参考技术（测压法）的性能。
在这项健康受试者的验证研究中，同时将研究用导管和固态测压导管放置在胃中。在禁食状态下记录胃动力 2.5 小时：2 小时，然后给予 400 千卡的液体餐，在剩余的半小时监测进食状态。通过自动识别和手动识别收缩活动比较两种系统的性能。数据表示为平均值（标准差）。
分析集包括 13 名健康受试者（6 名女性，年龄：27.5（8.1）岁，BMI：22.2（2.46）kg/m2）。两种技术的自动识别收缩性具有很强的相关性（终点：收缩持续时间；Spearman ρ=0.96，p<0.001）。专家在两种技术上独立识别的单个收缩数量之间也存在相关性（ρ=0.71，p=0.007），以及专家和 GMS 软件识别的收缩之间存在相关性（ρ=0.87，p=0.001）。未发生严重或意外的不良事件。
与金标准（测压法）的强相关性验证了 VIPUN GMS 作为胃动力监测系统的性能。
