ERASME
Brussels, 1070, Belgium
NCT Number: NCT04728477
Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients
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Notify Me18 year–99 year
All sexes
Observational
Brussels, 1070, Belgium
The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the radial arterial line)
All patients admitted in the intensive care unit at Erasme Hospital Brussels, Belgium will be recruited and if they have an arterial line for at least two days
The OptiBP Application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure.
Three measures will be taken (spaced by one minute) with both methods each hour for 5 hours and this will be done for 2 days.
The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line).
Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application.
The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the arterial line (gold standard)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
measurement of blood pressure with the new smartphone App ( OPTIBP)
Time frame: 48 hours
Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).
Time frame: at 48 hour
Identification of possible use error in the manipulation of the device and in the performance of the measure
Erasme University Hospital
Other
Accuracy, Precision and Trending Abilities of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients: A Method Comparison Study Against the Arterial Line as the Reference Method
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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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