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This is a clinical, data collection study conducted at one site. This study will collect open comments, user feedback and parameter raw data to support patient monitoring product development. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
This is a pre-market, open label, prospective, non-randomized, data collection clinical research study conducted at one investigational site. This study will collect open comments, user feedback and parameter raw data to support product development. Raw parameter data will be collected from electrocardiogram (ECG), Pulse Rate (PR), respiratory rate (RR), peripheral capillary oxygen saturation (SpO2), non-invasive blood pressure (NIBP), and temperature. Subjects participating in this study will be monitored with the site's standard of care primary monitor and the investigational device as the secondary monitor while enrolled in this study. No subject care decisions or diagnoses will be made based on information obtained from the investigational secondary monitor.
Participation is expected to last no more than 72 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory Monitoring Solution | Experimental | The evaluable device (Ambulatory Monitoring Solution and its parts) is a secondary monitoring device and no decisions/diagnosis will be made from these devices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory Monitoring Solution | Device | Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| User feedback | This is an early feasibility study intended to elicit user feedback in a hospital setting in order to improve device functionality and further development of the measurement algorithms. User feedback will be collected by open comments field in CRF. | through study completion, average of one day per subject |
| Collection of electronic parameter data | Electronic device files from patient sensors will be collected for each subject. | 2 hours up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety information | To collect safety information, including type and number of AEs, SAEs, and device issues. | through study completion and issues resolved, average of one day per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Satu Nikander | Contact | + 358 40 847 0008 | satu.nikander@ge.com |
| Name | Affiliation | Role |
|---|---|---|
| Rita Linko | Hospital District of Helsinki and Uusimaa | Principal Investigator |
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