The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring

February 3, 2025 updated by: Tampere University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Electrocardiography (ECG)
Time Frame: Continuous measurement 24 hours
Mean error an mean absolute error between the study device and standard monitor heart rae
Continuous measurement 24 hours
Plethysmography
Time Frame: Continuous measurement 24 hours
Mean error and mean absolute error between the study monitor and standard monitor
Continuous measurement 24 hours
Respiration rate
Time Frame: Continuous measurement 24 hours
Mean error and mean absolute error between the study monitor and standard monitor
Continuous measurement 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Continuous measurement 24 hours
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
Continuous measurement 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tampere University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jarkko Harju, Deputy chief physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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