Vital SignsNCT06117111
The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring
An observational study of Vital Signs, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vital Signs
- What is being tested?
- PaMo monitoring device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 20 Dec 2023to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The main study population is formed by adult patients entering to pancreatic or ear tumour surgery following postoperative intensive care treatment.
Who may be able to join
- Age: minimum of 18 years
- Undergoing pancreatic or ENT tumour surgery
- Ability to give informed consent
- Volunteering to the study
Who cannot join
- Age under 18 years
- Insufficient knowledge in Finnish
- Cardiac pacemaker
- Inability to give informed consent
- Denial
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- PaMo monitoring device
- Keywords
- vital signs, intraoperative monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaMo monitoring deviceDevice
Comparison of the device to standard monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PaMo monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocardiography (ECG)
Mean error an mean absolute error between the study device and standard monitor heart rae
Measured: Continuous measurement 24 hours
Plethysmography
Mean error and mean absolute error between the study monitor and standard monitor
Measured: Continuous measurement 24 hours
Respiration rate
Mean error and mean absolute error between the study monitor and standard monitor
Measured: Continuous measurement 24 hours
Secondary outcomes (2)
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
Measured: Continuous measurement 24 hours
blood pressure
blood pressure Mean error and mean absolute error between the study monitor and standard monitor and algorithm development
Measured: Continuous measurement 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start20 Dec 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Jarkko Harju, Principal investigator, Deputy chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117111
- Sponsor's protocol ID
- PAMO2023
- Status last verified
- Nov 2024
- First submitted
- 5 May 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Portable Wireless Monitor in Patient Vital Sign Monitoring
- ClinicalTrials.gov ID
- NCT06117111
- Acronym / sponsor ID
- PAMO2023
- Conditions
- Vital Signs
- Keywords
- vital signs, intraoperative monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: PaMo monitoring deviceAge: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The main study population is formed by adult patients entering to pancreatic or ear tumour surgery following postoperative intensive care treatment.
Key inclusion criteria (4 listed)
- Age: minimum of 18 years
- Undergoing pancreatic or ENT tumour surgery
- Ability to give informed consent
- Volunteering to the study
Key exclusion criteria (5 listed)
- Age under 18 years
- Insufficient knowledge in Finnish
- Cardiac pacemaker
- Inability to give informed consent
- Denial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaMo monitoring deviceComparison of the device to standard monitoring | Device | Study group |
Primary outcome
Electrocardiography (ECG)
Time frame: Continuous measurement 24 hours
Mean error an mean absolute error between the study device and standard monitor heart rae
Plethysmography
Time frame: Continuous measurement 24 hours
Mean error and mean absolute error between the study monitor and standard monitor
Respiration rate
Time frame: Continuous measurement 24 hours
Mean error and mean absolute error between the study monitor and standard monitor
2 secondary outcomes
usability
Time frame: Continuous measurement 24 hours
blood pressure
Time frame: Continuous measurement 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarkko Harju principal investigator
Deputy chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiography (ECG) (time frame: Continuous measurement 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.