on-contact vitals monitoring
Not Applicable
- Registration Number
- CTRI/2021/12/038849
- Lead Sponsor
- Turtle Shell Technologies Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adults (Above 18 years of age)
2. Provide written informed consent
3. Weight (Above 40 kgs)
4. Are located in a non-ICU hospital setting
5. Agree and able to not eat during the testing period
6. Agree and able to to keep still
Exclusion Criteria
1. Are connected to a device which may interfere with the device monitoring in this study,
eg. Airbeds
2. A likely need to receive or undergo a procedure/care during the testing period
3. Have a pacemaker or defibrillator
4. Cannot accept a nasal cannula, or have a monitor lead placed on the chest
5. A significant medical condition in the judgement of the investigator, which may
compromise the study testing procedures
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Root mean square deviation (RMSD) of the Dozeeâ??s HR and Gold Standard Devices <br/ ><br>HR <br/ ><br>â?? Simultaneously record HR in both devices and calculate and compare the <br/ ><br>RMSD per patient and the Bland-Altman Plot <br/ ><br>2. Root mean square deviation (RMSD) of the Dozeeâ??s RR and Gold Standard Devices <br/ ><br>RR <br/ ><br>â?? Simultaneously record RR in both devices and calculate and compare the <br/ ><br>RMSD per patient and the Bland-Altman Plot <br/ ><br>3. Root mean square deviation (RMSD) of the Dozeeâ??s SpO2 and Gold Standard Devices <br/ ><br>SpO2 <br/ ><br>â?? Simultaneously record SpO2 in both devices and calculate and compare the <br/ ><br>RMSD per patient and the Bland-Altman PlotTimepoint: At Baseline
- Secondary Outcome Measures
Name Time Method ILTimepoint: Not Applicable