Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults Male or female. (Above 18 years of age) 2. Provide written informed consent. 3. Weight between 40kg/88.18lbs and 120kg/264.55lbs 4. Agree to not eat during the testing period 5. Able to move and exit the bed independently and safely.
Exclusion criteria
Exclusion criteria: 1. Are connected to a device that may interfere with the device monitoring in this study. 2. Are receiving any bedside care which may be incompatible with the study procedures. 3. A likely need to receive or undergo a procedure during the testing period. 4. Cannot accept a nasal cannula, or have an ECG leads placed on the chest. 5. Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the Dozee device meets the predefined product specifications for accuracy in measuring HR, RR, Motion and Bed-Exit.Timepoint: At base line. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the agreement between Dozee and the gold standard reference device using Bland-Altman analysis for HR and RR.Timepoint: At base line.;To evaluate the correlation between Dozee and the reference device using Deming regression and Pearsonâ??s correlation coefficient for HR and RR.Timepoint: At base line.;To determine the detection rate and range of HR and RR measured by Dozee.Timepoint: At base line.;To benchmark the performance of the latest Dozee algorithm in comparison with other versions through retrospective analysis using the collected BCG data.Timepoint: At base line. | — |
Countries
India
Contacts
Turtle Shell Technologies Pvt Ltd