The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

Vital Signs Clinical Trial

Official title:

The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117111
• Other study ID #: PAMO2023
• Status: Recruiting
• Start date: December 20, 2023
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Tampere University Hospital
• Contact: Jarkko Harju
• Phone: 03 311 65368
• Email: jarkko.harju[@]pirha.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vital Signs

Intervention

Device:
• PaMo monitoring device
Comparison of the device to standard monitoring

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrocardiography (ECG)	Mean error an mean absolute error between the study device and standard monitor heart rae	Continuous measurement 24 hours
Primary	Plethysmography	Mean error and mean absolute error between the study monitor and standard monitor	Continuous measurement 24 hours
Primary	Respiration rate	Mean error and mean absolute error between the study monitor and standard monitor	Continuous measurement 24 hours
Secondary	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
Secondary	blood pressure	blood pressure Mean error and mean absolute error between the study monitor and standard monitor and algorithm development	Continuous measurement 24 hours