NCT04585178

Screening for Postoperative Vital Signs Abnormalities, and Particularly Hemodynamic Ones, by Continuous Monitoring Using the Biobeat Patch

Detection of Postoperative Complications and Particularly Hemodynamic Ones Through Continuous Monitoring Using the Biobeat Patch

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brief Summary: Post-operative morbidity remains a reality as shown by the International Surgical Outcomes Study published in 2016 and 2019 and by several recent publications which focus mainly on hypotension and cardio-vascular complications. Other complications, such as respiratory depression, are less often studied. The hypothesis is that this connected patch could be used in surgical departments to detect a postoperative complication. Biobeat Technologies Ltd has developed a sensor which continuously records the photoplethysmographic waveform and allows the calculation of several physiological parameters: heart rate (HR), oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), respiratory rate (RR), and temperature. The objective of this study is the quantification of hemodynamic, respiratory and temperature abnormalities detected by routine monitoring (routine nursing follow-up) and continuous monitoring by the Biobeat patch during the first 72 postoperative hours.

Conditions

• Surgery--Complications

Interventions

Type	Name	Description
DEVICE	Biobeat patch	The Biobeat device (BB-613WP) is a class IIa medical device and is a non-invasive patch used for monitoring vital signs in clinical and non-clinical settings. The sensor continuously records the photoplethysmographic waveform that allows the calculation of several physiological parameters: heart rate (HR), SPO2, systolic blood pressure (SBP) and change in SBP, diastolic blood pressure (DBP) and change in DBP, stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), and respiration rate (RR). Translated with www.DeepL.com/Translator (free version)

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2020-10-14
• Last updated: 2024-06-14

Locations

2 sites across 1 country: France