The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

NCT ID: NCT06117111

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-12-20

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 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.

Conditions

Vital Signs

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

PaMo monitoring device

Intervention Type: DEVICE

Comparison of the device to standard monitoring

Interventions

PaMo monitoring device

Comparison of the device to standard monitoring

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jarkko Harju

Role: PRINCIPAL_INVESTIGATOR

Deputy chief physician

Locations

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

PAMO2023

Identifier Type: -

Identifier Source: org_study_id