N/A
Completed N=100
Validation of a Vital Signs Monitoring Wristband
Source: ClinicalTrials.gov NCT05566886 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: RMSE of Heart Rate — 1.3 beats per minute
Summary
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.
This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RMSE of Heart Rate |
1.3 | — |
| PRIMARY RMSE of Respiratory Rate |
0.9 | — |
| PRIMARY RMSE of Oxygen Saturation |
1.6 | — |
| PRIMARY RMSE of Blood Pressure |
3.7; 2.5 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years old;
- undergoing invasive monitoring, like coronary angiography;
- able to provide consent.
Exclusion Criteria
Patients
- who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
- unable or not willing to sign informed consent;
- with significant mental or cognitive impairment;
- who do not have a suitable entry site for the invasive arterial line
- who do not comply to criteria established by ISO 81060-2:2018.
Data sourced from ClinicalTrials.gov (NCT05566886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.