Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
None listed
Sponsors
Turtle Shell Technologies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Consenting adults ( >18 years old) who are healthy individuals or patients undergoing treatment in the hospital (OPD, General wards, Emergency wards) 2. Weight between 40kg-150kgs 3. They/legal representative are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Weight below 40 kgs and above 150 kgs 2. Currently pregnant 3. Exhibit injuries, deformities, or other abnormalities that, in the opinion of the investigator, may prevent proper placement of accessories 4. Level of agitation or non-compliance too high to enroll 5. Needs the use of equipments whose operation can interfere with Dozeeâ??s signal 6. A significant medical condition in the judgment of the investigator, which may compromise the study testing procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean absolute Error (MAE) of Dozeeâ??s vitals parameters, HR, HRV, RR, BP, Temperature and SpO2 in comparison with the gold standard and or equivalent devices 2. Motion Notification Accuracy (%), Bed Exit Notification Accuracy and Posture Accuracy (%) of the Dozee in comparison with equivalent devices and manual observations. 3. Dozeeâ??s sensitivity in the detection of heart rhythms in comparison with the gold standard method.Timepoint: At Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dozees detection rate and/or detection range of HR, HRV, RR, BP, SpO2, cardiac rhythms in comparison to the gold standard and/or equivalent devices in various hospital bed/mattress setups and environmental conditions.Timepoint: At Baseline | — |
Countries
India
Contacts
Public ContactPooja Kadambi
Turtle Shell Technologies
Outcome results
None listed