Alar SpO2 Sensor Study (NCT06398262) | Clinical Trial Compass
CompletedNot Applicable
Alar SpO2 Sensor Study
Sweden56 participantsStarted 2024-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Through study completion, estimated within 6 months
2
Paired sensitivity
Timeframe: Through study completion, estimated within 6 months
3
Average time difference in desaturation detection between the Alar SpO2 sensor and the finger SpO2 sensor
Timeframe: Through study completion, estimated within 6 months