Oxygen Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2024 |
Est. primary completion date | September 22, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Philips Clinical & Medical Affairs Global | Karolinska University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Paired sensitivity | sensitivity of the Alar SpO2 sensor vs. sensitivity of the finger SpO2 sensor | Through study completion, estimated within 6 months | |
Primary | 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 | 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 | Through study completion, estimated within 6 months | |
Secondary | Detection of desaturation events | Percentage of desaturation events detected by both SpO2 sensors | Through study completion, estimated within 6 months | |
Secondary | Number of technical alarms for both SpO2 sensors. | Number of technical alarms for both SpO2 sensors. | Through study completion, estimated within 6 months | |
Secondary | 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. | Through study completion, estimated within 6 months | |
Secondary | Staff experience and satisfaction | score for the Alar SpO2 sensorQualitative evaluation of nurse experience via semi-structured interviews | Through study completion, estimated within 6 months |
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