Testing Dozee’s Contactless Vital Sign Measurements

Phase 2

• Conditions: Health Condition 1: 4- Measurement and Monitoring

• Registration Number: CTRI/2024/08/071959
• Lead Sponsor: Turtle Shell Technologies Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Consenting adults 18 to 99 years ICU patients

They or legal representative are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent

For NcBP Patients already on radial ABP line or whose BP is measured using cuff BP

For RR Patients on continuous capnography monitoring

For HR patients on continuous ECG monitoring

Patients who have been screened for HR RR and or NcBP can be included for the data collection of SpO2 temperature and NiBP data.

Exclusion Criteria

Currently pregnant

Exhibit injuries deformities or other abnormalities that in the opinion of the investigator, may prevent proper placement of accessories

Level of agitation or non-compliance too high to enroll

Needs the use of equipments whose operation can interfere with Dozee signal

A significant medical condition in the judgment 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
Mean Absolute Error (MAE) of Dozee NcBP across the range of each vitals <br/ ><br>in comparison to gold standardTimepoint: At baseline

Secondary Outcome Measures

Name	Time	Method
MAE of Dozee RR in comparison to gold standard <br/ ><br>MAE of Dozee HR in comparison to gold standard <br/ ><br>MAE of Dozee NcBP RR and HR in comparison to gold standard across <br/ ><br>different comorbidities <br/ ><br>MAE of Dozee CE or and FDA approved contact based accessories <br/ ><br>Bland-Altman analysis of the Dozee NcBP RR and HR in comparison to gold <br/ ><br>standard <br/ ><br>Deming Regression analysis and Pearson coefficient of the Dozee NcBP RR and HR in comparison to gold standardTimepoint: Baseline