Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04585178
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2020-10-05
Brief Title:
Screening for Postoperative Vital Signs Abnormalities and Particularly Hemodynamic Ones by Continuous Monitoring Using the Biobeat Patch
Sponsor:
Hopital Foch
Organization:
Hopital Foch
Study Overview
Official Title:
Detection of Postoperative Complications and Particularly Hemodynamic Ones Through Continuous Monitoring Using the Biobeat Patch
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Biobeat-Postop
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None