Karolinska hospital
Stockholm, Sweden
NCT Number: NCT06398262
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.
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Notify Me18 year and older
All sexes
Observational
Stockholm, Sweden
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Through study completion, estimated within 6 months
Percentage of monitoring time with a perfusion indicator >0.3% for each
Time frame: Through study completion, estimated within 6 months
sensitivity of the Alar SpO2 sensor vs. sensitivity of the finger SpO2 sensor
Time frame: Through study completion, estimated within 6 months
calculated from desaturation onset and nadir
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
Time frame: Through study completion, estimated within 6 months
Percentage of desaturation events detected by both SpO2 sensors
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
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.
Time frame: Through study completion, estimated within 6 months
score for the Alar SpO2 sensorQualitative evaluation of nurse experience via semi-structured interviews
Philips Clinical & Medical Affairs Global
Industry
MA_MCS_Alar SpO2 Sensor Pilot study_2020_11181
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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