Hypertension Cardiovascular Diseases
Conditions
Interventions
It is a study of diagnostic accuracy, with a cross-sectional design and prospective collection. The study aims to make a clinical evaluation by cross-validation, of the accuracy, sensitivity, specific
complementation study, only after the successful completion of the first phase, another 335 participants will be investigated, totaling a minimum validated sample of 420 individuals. The 420 participa
Sponsors
Programa de Pós-Graduação em Informática em Saúde-PPGINFOS
Programa de Pós-Graduação em Informática em Saúde-PPGINFOS
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals aged 18 years or older; Admitted to the Polydoro Ernani de São Thiago University Hospital of the Brazilian Hospital Services Company/Brazilian Hospital Services Company (HU-UFSC/EBSERH); Selected by convenience sampling from individuals seeking triage services; Agreeing to participate in the study and signing the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if they present any of the following: bilateral upper limb disabilities; upper limb skin color alterations; severe upper limb peripheral arterial disease; significant upper limb edema; an implanted pulse generator (cardiac pacemaker); skin allergy to alcohol; infectious skin diseases; inability or unwillingness to sign the informed consent form; or any other conditions in which the investigators deem the patient's participation in the trial inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity, specificity, accuracy, and error rate of the Heart Rate (HR), Systolic and Diastolic Blood Pressure (SBP/DBP), and Peripheral Oxygen Saturation (SpO2) estimates obtained by the medical device based on photoplethysmography (PPG) under evaluation are expected to be in agreement with the non-invasive gold-standard equipment used in routine hospital triage. | — |
Secondary
| Measure | Time frame |
|---|---|
| The device under evaluation is expected to present reliability of the obtained data across different phenotypic and demographic characteristics of the population.;The device under evaluation is expected to present good acceptability, ease of handling, and the technology is not expected to introduce workload overhead in the dynamic environment of hospital triage. | — |
Countries
BR
Contacts
Public ContactAna Miranda
Programa de Pós-Graduação em Informática em Saúde
Outcome results
None listed