Alar SpO2 Sensor Study

NCT06398262 | Completed

• 1 other identifier: Alar SpO2 sensor Pilot study
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nasal Alar Collapse, Bilateral; Oxygen; Measurement; SpO2

Outcome Measures

Primary Outcomes (3)

• 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

  Through study completion, estimated within 6 months

• Paired sensitivity

  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

  calculated from desaturation onset and nadir

  Through study completion, estimated within 6 months

Secondary Outcomes (5)

• Performance of both SpO2 sensors in comparison to a CO-oximetry

  Through study completion, estimated within 6 months

• Detection of desaturation events

  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

  Through study completion, estimated within 6 months

• Staff experience and satisfaction

  Through study completion, estimated within 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: collaborator
• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Karolinska hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Nasal Alar Collapse, Bilateral

Study Officials

• Gabriel Dumitrescu, Prof. Dr.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: May 3, 2024
• Study Start: September 24, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)