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Completed

NCT Number: NCT06117111

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PaMo monitoring device

Device

Comparison of the device to standard monitoring

Primary outcomes

  1. Electrocardiography (ECG)

    Time frame: Continuous measurement 24 hours

    Mean error an mean absolute error between the study device and standard monitor heart rae

  2. Plethysmography

    Time frame: Continuous measurement 24 hours

    Mean error and mean absolute error between the study monitor and standard monitor

  3. Respiration rate

    Time frame: Continuous measurement 24 hours

    Mean error and mean absolute error between the study monitor and standard monitor

Secondary outcomes

  1. usability

    Time frame: Continuous measurement 24 hours

    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

  2. blood pressure

    Time frame: Continuous measurement 24 hours

    blood pressure Mean error and mean absolute error between the study monitor and standard monitor and algorithm development

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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