Alar SpO2 Sensor Study

December 2, 2025 updated by: Philips Clinical & Medical Affairs Global

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.

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.

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 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.
56

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

  • Sweden
      • Stockholm, Sweden
        • Karolinska 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

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

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.
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 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
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
Through study completion, estimated within 6 months
Paired sensitivity
Time Frame: Through study completion, estimated within 6 months
sensitivity of the Alar SpO2 sensor vs. sensitivity of the finger SpO2 sensor
Through study completion, estimated within 6 months
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
Through study completion, estimated within 6 months

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
Performance of both SpO2 sensors in comparison to a CO-oximetry
Time Frame: Through study completion, estimated within 6 months
Performance will be measured bu calculating Bias, Precision, Accuracy, root mean square error (ARMS), Intra-/inter-subject variability and Limits of agreement
Through study completion, estimated within 6 months
Detection of desaturation events
Time Frame: Through study completion, estimated within 6 months
Percentage of desaturation events detected by both SpO2 sensors
Through study completion, estimated within 6 months
Number of technical alarms for both SpO2 sensors.
Time Frame: Through study completion, estimated within 6 months
Number of technical alarms for both SpO2 sensors.
Through study completion, estimated within 6 months
Staff experience and satisfaction
Time Frame: Through study completion, estimated within 6 months
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.
Through study completion, estimated within 6 months
Staff experience and satisfaction
Time Frame: Through study completion, estimated within 6 months
score for the Alar SpO2 sensorQualitative evaluation of nurse experience via semi-structured interviews
Through study completion, estimated within 6 months

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.
Philips Clinical & Medical Affairs Global

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.
Karolinska University Hospital

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: Gabriel Dumitrescu, Prof. Dr., Karolinska Institutet

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.
September 24, 2024

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.
November 7, 2025

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.
November 7, 2025

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).
March 6, 2024

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.
May 2, 2024

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.
May 3, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
December 4, 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.
December 2, 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.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • Alar SpO2 sensor Pilot study

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

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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