SpO2NCT06398262
Alar SpO2 Sensor Study
An observational study of SpO2 and Nasal Alar Collapse, Bilateral, run by Philips Clinical & Medical Affairs Global at 1 site in Sweden.
Trial summary
BACKGROUND: As the normal functioning of the body is dependent on oxygen, low blood oxygenation is a acute problem that needs immediate attention. Measurement of blood oxygenation is therefore central to monitor patients and is usually done using light technology with a clip on the finger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen
- How many people
- 56 participants
- Where
- 1 siteSweden
- Study dates
- 24 Sep 2024to 7 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in surgical patients in the peri-operative unit of Karolinska University Hospital (Huddinge site), Stockholm, Sweden and will focus on patients after upper abdominal surgery. In order to ensure a balanced distribution of men and women, at a minimum 40% of the total subject population will be male and 40% will be female.
Who may be able to join
- Age 18 or older
- Standard of care for planned abdominal surgery foresees continuous SpO2 monitoring intra- and post-operatively
- Standard of care for planned abdominal surgery foresees arterial catheterization in order to aspirate blood for blood gas analysis
- Expected overnight stay in the peri-operative unit
- Able to speak and understand Swedish
- Willing and able to provide written informed consent
Who cannot join
- Body weight below 50 kg
- Procedures and/or conditions affecting the face or hands that might prevent placement of sensors
- Injury/wounds or physical malformation of sensor application sites (i.e. nose, fingers)
- Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
- Nail fungus on application site
- Refusal to remove artificial nails or nail polish
Show all 14Show fewer
- Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
- Raynaud's disease
- Hemoglobinopathy
- Expected post operative ward stay ≤12 hrs
- Dye injections within 48 hours
- Pregnant or lactating during the study period
- Nasal intubation
- Patient is participating in another medical device study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MA_MCS_Alar SpO2 Sensor Pilot study_2020_11181
BACKGROUND: As the normal functioning of the body is dependent on oxygen, low blood oxygenation is a acute problem that needs immediate attention. Measurement of blood oxygenation is therefore central to monitor patients and is usually done using light technology with a clip on the finger. Philips manufactures a measuring clip that is designed to measure oxygenation in the nasal wing instead of the finger. The advantage of this is that the nose is not affected as much as the fingers by poor blood flow in the skin, for example caused by cold. The nose is also closer to the heart and lungs than the hand, so changes in oxygenation may be detected earlier. This newer meter is an approved CE-marked product that is available for clinical use, but the next step is to investigate it systematically during and after surgery.
Read the detailed description
METHODS: The study intends to include patients undergoing planned major surgery at the surgery department at Karolinska University Hospital Huddinge. Before surgery, patients will be asked and written informed consent for participation will be obtained. Within the framework of the study, measurement with the newer measurement method on the nose is planned to be done at the same time as standard measurement on the finger is performed. The research study and oxygen saturation measurement with the nasal clamp starts when the patient enters the operating room and continues until he or she leaving the post-operative ward the day after surgery, or at the latest 24 hours after the start of the operation. Apart from the use of two body oxygenation monitors, there is no impact on the treatment and care are not affected at all. Decisions and actions based on possible changes in oxygenation will be based primarily on the traditional measurement point in the finger. After completion of the study, all anesthesia nurses and all nurses from the surgical and postoperative department in Huddinge who have worked with the Alar SpO2 (saturation) sensor during the study will be invited to participate in a semi-structured interview. All nurses who express interest in participating will receive an information sheet and consent will be signed personally with the signed personally with the interviewer before the interview starts. The investigators will collect data on staff opinions regarding the use of the Alar SpO2 sensor (such as: the differences between the Alar SpO2 sensor and the finger SpO2 sensor, the advantages and disadvantages of the Alar SpO2 sensor, advantages of using dual oximetry, and potential expansion of the work with the Alar SpO2 sensor).
- Conditions
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement
- Medical subject headings
- Nasal Alar Collapse, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | This study will be conducted in surgical patients in the peri-operative unit of Karolinska University Hospital (Huddinge site), Stockholm, Sweden and will focus on patients after upper abdominal surgery. In order to ensure a balanced distribution of men and women, at a minimum 40% of the total subject population will be male and 40% will be female. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of monitoring time with a perfusion indicator >0.3% for each of the two SpO2 sensors sufficient to reliably detect desaturations of both SpO2 sensors
Percentage of monitoring time with a perfusion indicator >0.3% for each
Measured: Through study completion, estimated within 6 months
Paired sensitivity
sensitivity of the Alar SpO2 sensor vs. sensitivity of the finger SpO2 sensor
Measured: Through study completion, estimated within 6 months
Average time difference in desaturation detection between the Alar SpO2 sensor and the finger SpO2 sensor
calculated from desaturation onset and nadir
Measured: Through study completion, estimated within 6 months
Secondary outcomes (5)
Performance of both SpO2 sensors in comparison to a CO-oximetry
Performance will be measured bu calculating Bias, Precision, Accuracy, root mean square error (ARMS), Intra-/inter-subject variability and Limits of agreement
Measured: Through study completion, estimated within 6 months
Detection of desaturation events
Percentage of desaturation events detected by both SpO2 sensors
Measured: Through study completion, estimated within 6 months
Number of technical alarms for both SpO2 sensors.
Number of technical alarms for both SpO2 sensors.
Measured: Through study completion, estimated within 6 months
Staff experience and satisfaction
System Usability Scale (SUS). The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. Participants can score every item from 1 (strongly disagree) to 5 (strongly agree). The higher they score, the more they like the system/device.
Measured: Through study completion, estimated within 6 months
Staff experience and satisfaction
score for the Alar SpO2 sensorQualitative evaluation of nurse experience via semi-structured interviews
Measured: Through study completion, estimated within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start24 Sep 2024
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpO2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Gabriel Dumitrescu, Prof. Dr., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398262
- Sponsor's protocol ID
- Alar SpO2 sensor Pilot study
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2024
- Last updated
- 4 Dec 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MA_MCS_Alar SpO2 Sensor Pilot study_2020_11181
- ClinicalTrials.gov ID
- NCT06398262
- Acronym / sponsor ID
- Alar SpO2 sensor Pilot study
- Conditions
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska University Hospital
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 3 May 2024 (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.
BACKGROUND: As the normal functioning of the body is dependent on oxygen, low blood oxygenation is a acute problem that needs immediate attention. Measurement of blood oxygenation is therefore central to monitor patients and is usually done using light technology with a clip on the finger. Philips manufactures a measuring clip that is designed to measure oxygenation in the nasal wing instead of the finger. The advantage of this is that the nose is not affected as much as the fingers by poor blood flow in the skin, for example caused by cold. The nose is also closer to the heart and lungs than the hand, so changes in oxygenation may be detected earlier. This newer meter is an approved CE-marked product that is available for clinical use, but the next step is to investigate it systematically during and after surgery.
Detailed description
METHODS: The study intends to include patients undergoing planned major surgery at the surgery department at Karolinska University Hospital Huddinge. Before surgery, patients will be asked and written informed consent for participation will be obtained. Within the framework of the study, measurement with the newer measurement method on the nose is planned to be done at the same time as standard measurement on the finger is performed. The research study and oxygen saturation measurement with the nasal clamp starts when the patient enters the operating room and continues until he or she leaving the post-operative ward the day after surgery, or at the latest 24 hours after the start of the operation. Apart from the use of two body oxygenation monitors, there is no impact on the treatment and care are not affected at all. Decisions and actions based on possible changes in oxygenation will be based primarily on the traditional measurement point in the finger. After completion of the study, all anesthesia nurses and all nurses from the surgical and postoperative department in Huddinge who have worked with the Alar SpO2 (saturation) sensor during the study will be invited to participate in a semi-structured interview. All nurses who express interest in participating will receive an information sheet and consent will be signed personally with the signed personally with the interviewer before the interview starts. The investigators will collect data on staff opinions regarding the use of the Alar SpO2 sensor (such as: the differences between the Alar SpO2 sensor and the finger SpO2 sensor, the advantages and disadvantages of the Alar SpO2 sensor, advantages of using dual oximetry, and potential expansion of the work with the Alar SpO2 sensor).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –This study will be conducted in surgical patients in the peri-operative unit of Karolinska University Hospital (Huddinge site), Stockholm, Sweden and will focus on patients after upper abdominal surgery. In order to ensure a balanced distribution of men and women, at a minimum 40% of the total subject population will be male and 40% will be female. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in surgical patients in the peri-operative unit of Karolinska University Hospital (Huddinge site), Stockholm, Sweden and will focus on patients after upper abdominal surgery. In order to ensure a balanced distribution of men and women, at a minimum 40% of the total subject population will be male and 40% will be female.
Key inclusion criteria (6 listed)
- Age 18 or older
- Standard of care for planned abdominal surgery foresees continuous SpO2 monitoring intra- and post-operatively
- Standard of care for planned abdominal surgery foresees arterial catheterization in order to aspirate blood for blood gas analysis
- Expected overnight stay in the peri-operative unit
- Able to speak and understand Swedish
Key exclusion criteria (14 listed)
- Body weight below 50 kg
- Procedures and/or conditions affecting the face or hands that might prevent placement of sensors
- Injury/wounds or physical malformation of sensor application sites (i.e. nose, fingers)
- Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
- Nail fungus on application site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of monitoring time with a perfusion indicator >0.3% for each of the two SpO2 sensors sufficient to reliably detect desaturations of both SpO2 sensors
Time frame: Through study completion, estimated within 6 months
Percentage of monitoring time with a perfusion indicator >0.3% for each
Paired sensitivity
Time frame: Through study completion, estimated within 6 months
sensitivity of the Alar SpO2 sensor vs. sensitivity of the finger SpO2 sensor
Average time difference in desaturation detection between the Alar SpO2 sensor and the finger SpO2 sensor
Time frame: Through study completion, estimated within 6 months
calculated from desaturation onset and nadir
5 secondary outcomes
Performance of both SpO2 sensors in comparison to a CO-oximetry
Time frame: Through study completion, estimated within 6 months
Detection of desaturation events
Time frame: Through study completion, estimated within 6 months
Number of technical alarms for both SpO2 sensors.
Time frame: Through study completion, estimated within 6 months
Staff experience and satisfaction
Time frame: Through study completion, estimated within 6 months
Staff experience and satisfaction
Time frame: Through study completion, estimated within 6 months
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 4 Dec 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.
Gabriel Dumitrescu, Prof. Dr. principal investigator
Karolinska Institutet
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 SpO2 and Nasal Alar Collapse, Bilateral, run by Philips Clinical & Medical Affairs Global at 1 site in Sweden.
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 14 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 4 Dec 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 Sweden. 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?
Percentage of monitoring time with a perfusion indicator >0.3% for each of the two SpO2 sensors sufficient to reliably detect desaturations of both SpO2 sensors (time frame: Through study completion, estimated within 6 months). 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 4 Dec 2025.