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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02790-53 | Other Identifier | ANSM |
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This study represents the first step for testing this device in patients in real-life situations to evaluate the technological capacities and usability by the patient
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Outpatients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| issued with SMART ANGEL device | Device | patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 0 |
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 1 |
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 2 |
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 3 |
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 4 |
| Number of measures recorded using tablet for blood pressure, cardiac frequency and oxygen saturation | Data collected and transmitted | Day 5 |
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 0 |
| Concordance between data collected on tablet versus paper copies |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use of medical device according to patient | System Usability Scale (SUS) : score 0-100 | Day 5 |
| Qualitative decision-making ability from pooled results of all data from all patients | Group of 2 experts decide whether patients should have been hospitalized, called, or left alone based on retrospective analysis of all data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Cuvillon | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032541 | Result | Chevallier T, Buzancais G, Occean BV, Rataboul P, Boisson C, Simon N, Lannelongue A, Chaniaud N, Gricourt Y, Lefrant JY, Cuvillon P. Feasibility of remote digital monitoring using wireless Bluetooth monitors, the Smart Angel app and an original web platform for patients following outpatient surgery: a prospective observational pilot study. BMC Anesthesiol. 2020 Oct 8;20(1):259. doi: 10.1186/s12871-020-01178-5. |
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Percentage correct measures |
| Day 1 |
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 2 |
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 3 |
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 4 |
| Concordance between data collected on tablet versus paper copies | Percentage correct measures | Day 5 |
| End of inclusion: Month 18 |
| Readmission rate | Percentage of patients readmitted to hospital | Month 1 |
| Qualitative decision-making ability from pooled results of all data from all patients on readmittance rate | Group of 2 experts decide whether patients should have been readmitted based on retrospective analysis of all data | End of inclusion period: Month 18 |