Vital Sign MonitoringNCT07676227
Pulse Oximetry Performance Test for PaMo - Controlled Desaturation Test
A study testing Hypoxia, intermittent in people with Vital Sign Monitoring and Vital Signs, run by Tampere University at 1 site in Finland.
Trial summary
The purpose of this study is to gather measurement data for the development and testing of a wearable patient monitor's pulse oximeter. The PaMo patient monitor measures respiratory rate, blood oxygen saturation, and electrocardiogram (ECG). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Sign Monitoring, Vital Signs
- What is being tested?
- Hypoxia, intermittent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- 19 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: minimum of 18 years and max 40 years
- ASA category 1
- positive Allen's test
- Passing the physical examination
- Ability to give informed consent
- Volunteering to the study
Who cannot join
- Age under 18 or over 40 years
- Smoker
- Pregnancy
- Does not pass the physical examination
- Negative Allen's test
- Relevant medical illnesses
Show all 12Show fewer
- Cardiovascular disease
- Pulmonary disease
- Insufficient knowledge in Finnish or English
- Cardiac pacemaker
- Inability to give informed consent
- Denial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to gather measurement data for the development and testing of a wearable patient monitor's pulse oximeter. The PaMo patient monitor measures respiratory rate, blood oxygen saturation, and electrocardiogram (ECG). The device transmits data via Bluetooth to a mobile application for immediate interpretation. The device, developed at Tampere University, aims to provide a wireless solution for monitoring patients' breathing and circulation, especially after surgical procedures. The collected data will be used to demonstrate the device's oxygen saturation measurement capability according to the European ISO 80601-2-61:2019 standard, contributing to further refinement of the solution.
Read the detailed description
The study involves controlled desaturation for voluntary participants, gradually lowering blood oxygen levels by reducing the inhaled air's oxygen content. This reduction is facilitated by the Hypoxico device, simulating high-altitude conditions. The device, connected to a transparent tent placed over subject's upper body, gradually decreases the surrounding air's oxygen content. Oxygen saturation is lowered to a minimum of 70%, and the measurement period lasts a maximum of 30 minutes. A physician and two research team members will be present throughout the measurement. Vital signs, including respiratory rate, heart's electrical activity, blood pressure, and oxygen saturation, will be monitored using the patient monitor in addition to the device being studied. Carbon dioxide levels in exhaled breath will be measured using nasal cannulas.
Reference devices:
Masimo RAD-97 pulse oximeter is a class IIB device and leading technology in measuring SpO2 and has demonstrated high sensitivity and accuracy even during conditions of motion and low perfusion. SpO2 and pulse will be monitored during the measurement period.
GE Carescape B450 is a class IIB device and globally used patient monitor with highly sophisticated algorithms for arrhythmia, non-invasive blood pressure and SpO2. 5-digit ECG, non-invasive blood pressure, IP, SpO2 and pulse will be monitored during the measurement period.
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 Sign Monitoring, Vital Signs
- Being tested
- Hypoxia, intermittent
- Keywords
- pulse oximetry, vital sign monitoring, controlled desaturation, ISO 80601-2-61:2019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia, intermittentDevice
Controlled hypoxia induced with Hypoxico device
| Study group | Role | What they receive |
|---|---|---|
| Controlled desaturation for healthy volunteers | Experimental | Not described Receives: Device: Hypoxia, intermittent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Oxygen Saturation Accuracy
Average root mean square (ARMS) difference compared with reference device
Measured: Continuous measurement up to 30 minutes
Secondary outcomes (1)
Hypoxia Detection
SpO2 ≤92%
Measured: Continuous measurement up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start19 Jan 2024
- Primary completion10 Jun 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Sign MonitoringStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antti Vehkaoja, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676227
- Sponsor's protocol ID
- PamoSpO2
- Status last verified
- Jun 2026
- First submitted
- 15 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximetry Performance Test for PaMo - Controlled Desaturation Test
- ClinicalTrials.gov ID
- NCT07676227
- Acronym / sponsor ID
- PamoSpO2
- Conditions
- Vital Sign Monitoring, Vital Signs
- Keywords
- pulse oximetry, vital sign monitoring, controlled desaturation, ISO 80601-2-61:2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 30 Jun 2026 (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.
The purpose of this study is to gather measurement data for the development and testing of a wearable patient monitor's pulse oximeter. The PaMo patient monitor measures respiratory rate, blood oxygen saturation, and electrocardiogram (ECG). The device transmits data via Bluetooth to a mobile application for immediate interpretation. The device, developed at Tampere University, aims to provide a wireless solution for monitoring patients' breathing and circulation, especially after surgical procedures. The collected data will be used to demonstrate the device's oxygen saturation measurement capability according to the European ISO 80601-2-61:2019 standard, contributing to further refinement of the solution.
Detailed description
The study involves controlled desaturation for voluntary participants, gradually lowering blood oxygen levels by reducing the inhaled air's oxygen content. This reduction is facilitated by the Hypoxico device, simulating high-altitude conditions. The device, connected to a transparent tent placed over subject's upper body, gradually decreases the surrounding air's oxygen content. Oxygen saturation is lowered to a minimum of 70%, and the measurement period lasts a maximum of 30 minutes. A physician and two research team members will be present throughout the measurement. Vital signs, including respiratory rate, heart's electrical activity, blood pressure, and oxygen saturation, will be monitored using the patient monitor in addition to the device being studied. Carbon dioxide levels in exhaled breath will be measured using nasal cannulas.
Reference devices:
Masimo RAD-97 pulse oximeter is a class IIB device and leading technology in measuring SpO2 and has demonstrated high sensitivity and accuracy even during conditions of motion and low perfusion. SpO2 and pulse will be monitored during the measurement period.
GE Carescape B450 is a class IIB device and globally used patient monitor with highly sophisticated algorithms for arrhythmia, non-invasive blood pressure and SpO2. 5-digit ECG, non-invasive blood pressure, IP, SpO2 and pulse will be monitored during the measurement period.
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controlled desaturation for healthy volunteers | Experimental | Device: Hypoxia, intermittent |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: minimum of 18 years and max 40 years
- ASA category 1
- positive Allen's test
- Passing the physical examination
- Ability to give informed consent
Key exclusion criteria (12 listed)
- Age under 18 or over 40 years
- Smoker
- Pregnancy
- Does not pass the physical examination
- Negative Allen's test
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 |
|---|---|---|
| Hypoxia, intermittentControlled hypoxia induced with Hypoxico device | Device | Controlled desaturation for healthy volunteers |
Primary outcome
Blood Oxygen Saturation Accuracy
Time frame: Continuous measurement up to 30 minutes
Average root mean square (ARMS) difference compared with reference device
1 secondary outcome
Hypoxia Detection
Time frame: Continuous measurement up to 30 minutes
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 30 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia, intermittent in people with Vital Sign Monitoring and Vital Signs, run by Tampere University 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 6 inclusion and 12 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 30 Jun 2026. 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?
Blood Oxygen Saturation Accuracy (time frame: Continuous measurement up to 30 minutes). 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 30 Jun 2026.