Coronary Artery Disease
Conditions
Keywords
Vital signs, Blood pressure, Oxygen saturation, Heart rate, Respiratory rate
Brief 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.
Interventions
DEVICEContinuous measurement of photoplethysmography at the wrist
Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.
Sponsors
Corsano Health B.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RMSE of Heart Rate | 30 minutes | Root-mean-squared error between PPG measured and gold standard measured heart rate |
| RMSE of Respiratory Rate | 30 minutes | Root-mean-squared error between PPG measured and gold standard measured respiratory rate |
| RMSE of Oxygen Saturation | 30 minutes | Root-mean-squared error between PPG measured and gold standard measured oxygen saturation |
| RMSE of Blood Pressure | 30 minutes | Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure) |
Countries
Netherlands
Participant flow
Pre-assignment details
124 subjects undergoing heart catheterization were screened. 24 participants were not included due to: * Lateral difference exceeding limits (n=8) * Arm circumference not within range (n=1) * Atrial fibrillation or arrhythmia (n=5) * Peripheral artery disease (n=3) * Unforeseen difficulties during procedure (n=2) * Other medical reasons (e.g., isolation for infection) (n=1) * Technical difficulties (measurement not started) (n=1) * Procedure canceled or postponed (n=3)
Participants by arm
| Arm | Count |
|---|---|
| Main Study Group Subjects undergoing heart catheterization as standard of care. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Main Study Group | — |
|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 11.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 33 Participants | — |
| Sex: Female, Male Male | 67 Participants | — |
| Skin colour (Fitzpatrick) Fitzpatrick Class I-II | 81 Participants | — |
| Skin colour (Fitzpatrick) Fitzpatrick Class III-IV | 16 Participants | — |
| Skin colour (Fitzpatrick) Fitzpatrick Class V-VI | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
RMSE of Blood Pressure
Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)
Time frame: 30 minutes
Population: 100 subjects were included, however, 3 individuals did not meet pre-specified dampening criteria~As a result data of 97 patients and 420 measurement pairs was included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study Group | RMSE of Blood Pressure | Systolic Blood Pressure | 3.7 mmHg | Standard Deviation 4.4 |
| Main Study Group | RMSE of Blood Pressure | Diastolic Blood Pressure | 2.5 mmHg | Standard Deviation 3.7 |
Primary
RMSE of Heart Rate
Root-mean-squared error between PPG measured and gold standard measured heart rate
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Main Study Group | RMSE of Heart Rate | 1.3 beats per minute |
Primary
RMSE of Oxygen Saturation
Root-mean-squared error between PPG measured and gold standard measured oxygen saturation
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Main Study Group | RMSE of Oxygen Saturation | 1.6 % of SpO2 |
Primary
RMSE of Respiratory Rate
Root-mean-squared error between PPG measured and gold standard measured respiratory rate
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Main Study Group | RMSE of Respiratory Rate | 0.9 breaths per minute |