Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117111
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-05-05
Brief Title:
The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring
Sponsor:
Tampere University Hospital
Organization:
Tampere University Hospital
Study Overview
Official Title:
The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
This clinical investigation assesses the performance of PaMo patient monitor system PaMo and its wearable sensing devices that combines continuous IP ECG and PPG in detecting developing respiratory depression episodes PaMo patient monitor system consists of a wearable measurement unit worn on a patient bedside mobile unit that receives the data from the wearable unit through Bluetooth Low Energy connection visualises it and can be relayed further to the central unit through WiFi network
Detailed Description:
Monitoring of voluntary subjects undergoing major surgery requiring postoperative intensive care treatment with PaMo patient monitoring device that includes continuous ECG respiration and PPG monitoring
The monitoring device is connected during anaesthesia preparation before induction of general anaesthesia and monitoring is continued throughout the surgery and in the intensive care unit ICU for total of 24 hours For reference data GE Carescape B850 patient monitors are used continuously for oxygen saturation ECG and respiration signals The data are collected from the reference patient monitor using a S5 collect software and a study computer In addition to obtain a gold standard reference for SpO2 with blood gas analyzer arterial samples are taken every two hours during anesthesia and in the ICU concurrently with the routine checkups During the surgery an arterial cannula collects continuous blood pressure data and can be used for taking blood samples The data collected with PaMo device and reference monitor are analyzed in Tampere University by researchers and used in device software and algorithm development
User experience information and usability feedback are collected at the end of the study from the medical staff with an interview form
The study does not include a control group All subjects are using the devices in similar way and the parameters collected from the same individual using two different methods are compared
The monitoring device is connected during anaesthesia preparation before induction of general anaesthesia and monitoring is continued throughout the surgery and in the intensive care unit ICU for total of 24 hours For reference data GE Carescape B850 patient monitors are used continuously for oxygen saturation ECG and respiration signals The data are collected from the reference patient monitor using a S5 collect software and a study computer In addition to obtain a gold standard reference for SpO2 with blood gas analyzer arterial samples are taken every two hours during anesthesia and in the ICU concurrently with the routine checkups During the surgery an arterial cannula collects continuous blood pressure data and can be used for taking blood samples The data collected with PaMo device and reference monitor are analyzed in Tampere University by researchers and used in device software and algorithm development
User experience information and usability feedback are collected at the end of the study from the medical staff with an interview form
The study does not include a control group All subjects are using the devices in similar way and the parameters collected from the same individual using two different methods are compared
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