The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Vital Signs
• Intervention / Treatment: Device: PaMo monitoring device

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 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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Jarkko Harju; Phone Number: 03 311 65368; Email: jarkko.harju@pirha.fi

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Recruiting
    • Tampere University Hospital
    • Contact: Jarkko Harju, MD; Phone Number: 00358331165368; Email: jarkko.harju@fimnet.fi
    • Principal Investigator: Jarkko Harju, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The main study population is formed by adult patients entering to pancreatic or ear tumour surgery following postoperative intensive care treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; 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; Comparison of the device to standard monitoring

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Tampere University
• Investigators: Principal Investigator: Jarkko Harju, Deputy chief physician

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: intraoperative monitoring; vital signs
• Other Study ID Numbers: PAMO2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No