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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05386836
Other study ID # PRO-367
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2022
Est. completion date June 21, 2022

Study information

Verified date June 2022
Source Sunrise
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter. Testing is conducted under normal office environment conditions. It is expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system will meet the required specification of ARMS of 3.5% or less allowed for reflectance technology in non-motion conditions for the range of 70-100% SaO2. A secondary goal is to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered.


Description:

Subjects will be given medical grade mixtures of oxygen and nitrogen to induce stable plateaus across the range of 100% to 70% SaO2. When the reference system's blood saturation stabilizes at an acceptable plateau level, blood sampling can start. Four to eight arterial blood samples will be collected for each plateau, while keeping at least 20 seconds in between each sample and at least 30 seconds once the plateau has been reached. The blood will be immediately analyzed by the reference CO-Oximeter to measure the arterial oxygen saturation (Functional SaO2). SpO2 values from the Sunrise sensor 2 will be collected electronically simultaneously to blood drawn from the indwelling catheter. Data will be collected under non-motion conditions. The pulse rate will be simultaneously collected over the SpO2 range covered. The reference method for the computation of pulse rate accuracy will be an ECG heart rate. The total duration of the test will be about 1 hour per subject. Data analysis results will provide documentation showing SpO2 and pulse rate accuracy performance of the Sunrise sensor 2 as compared to arterial blood samples measured by Reference CO-Oximetry and to ECG heart rate, respectively.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Subjects with positive Allen's test - Subject must be willing and able to comply with study procedures and duration - Subject is a non-smoker or who has not smoked within 2 days prior to the study - 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study Exclusion Criteria: - Subject is considered as being morbidly obese (defined as BMI >39.5) - Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study - Subjects with known heart or cardiovascular conditions - Subjects with other known health condition (diabetes, thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer/chemotherapy)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pulse oximeter validation population
Evaluation of the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from arterial blood sample specimen analyzed by a CO-oximeter.

Locations

Country Name City State
Belgium Respisom Namur

Sponsors (1)

Lead Sponsor Collaborator
Sunrise

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary SpO2 ARMS determination SpO2 accuracy root-mean-square (ARMS) determination for the range of 70- 100%., i.e., the RMS difference between measured values and reference values. Within 1 month after subject recruitment
Secondary Pulse rate ARMS determination Pulse rate accuracy root-mean-square (ARMS) determination Within 1 month after subject recruitment
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