Clinical validation of the VIPUN™ gastric monitoring system versus manometry for the evaluation of gastric motility.
Neurogastroenterol Motil
; 36(6): e14783, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38488253
ABSTRACT
BACKGROUND:
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.AIMS:
To compare the performance of the VIPUN GMS versus a reference technique (manometry).METHODS:
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). KEYRESULTS:
The analysis set comprised 13 healthy subjects (6 women, age 27.5 (8.1) years, BMI 22.2 (2.46) kg/m2). 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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Gastrointestinal Motility
/
Manometry
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
En
Journal:
Neurogastroenterol Motil
/
Neurogastroenterol. motil
/
Neurogastroenterology and motility
Journal subject:
GASTROENTEROLOGIA
/
NEUROLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Bélgica
Country of publication:
Reino Unido