Raafat Fares1, Leandro Fontana Pires2,3, Delphine Bouard1 , Christine Laigot1, Sébastien Judé1, Charles Eynard2, Timothé Flenet2, Pascal Champeroux1
1: ERBC Chemin de Montifault, 18800 Baugy, France
2: Univ. Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, TIMC, 38000 Grenoble, France
3: R&D, ETISENSE SAS, 16 RUE JEAN DESPARMET, 69008 LYON, France
Abstract
Dogs, one of the two main non-rodent species used in safety assessments for new chemical entities (NCEs), commonly integrate safety pharmacology endpoints such as ECG and respiratory recordings via jacket telemetry in toxicology studies. The Decro system, a miniaturized telemetry system previously validated in rats, offers several advantages, including the integration of respiratory, activity, and ECG recordings into a single setup, thereby reducing equipment handling time.
This study aimed to develop and validate an adjustable, one-size-fits-all jacket with integrated respiratory belts designed for dogs. Four Beagle dogs, each implanted with an invasive DSI telemetry system and housed in pairs, were outfitted with Decro jackets during two separate three-hour sessions. The dogs demonstrated good tolerance to the jackets with no observed clinical signs or changes in behavior. The Decro jackets successfully recorded ECG and respiratory signals, consistently achieving high-quality cardiac signal scores (>95%) and respiratory signal scores (>80%) throughout the recording periods. ECG signals acquired in Lead II configuration with the jackets were compared to those obtained with DSI. Statistical bias between both methods for heart rate was assessed using Bland-Altman analysis, which plots the difference against their mean values. The analysis revealed a bias of 0.6 beat per minute and an agreement limit of [-3.7, 4.9] beats per min (95% confidence interval).
In conclusion, the Decro jacket proves to be a reliable setup for integrating safety pharmacology endpoints into toxicology studies. Beyond its technical benefits, this solution holds significant promise for addressing hemodynamic parameters currently under investigation.
