The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

Study Overview
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Brief Summary
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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
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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 S/5 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.

Official Title
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The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

Conditions
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Accuracy of Vital Sign Estimation of PaMo System When Compared to Standard Monitoring

Intervention / Treatment
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* Device: PaMo monitoring device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: minimum of 18 years Undergoing pancreatic or ENT tumour surgery Ability to give informed consent Volunteering to the study Exclusion Criteria: Age under 18 years Insufficient knowledge in Finnish Cardiac pacemaker Inability to give informed consent Denial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Age: minimum of 18 years, Undergoing pancreatic or ENT tumour surgery, Ability to give informed consent, Volunteering to the study. Monitored in addition to standard monitoring using PaMo device. | Device: PaMo monitoring device<br>* Comparison of the device to standard monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiography (ECG) | Mean error an mean absolute error between the study device and standard monitor heart rae | Continuous measurement 24 hours | 
| Plethysmography | Mean error and mean absolute error between the study monitor and standard monitor | Continuous measurement 24 hours | 
| Respiration rate | Mean error and mean absolute error between the study monitor and standard monitor | Continuous measurement 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usability | usability of the evaluated patient monitoring solution for showing its usability, understandable user interface, suitability of the materials, unobtrusiveness, and fulfilment of related design input requirements. Questionnaire results | Continuous measurement 24 hours | 
| blood pressure | blood pressure Mean error and mean absolute error between the study monitor and standard monitor and algorithm development | Continuous measurement 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vital signs, intraoperative monitoring