Examining how continuous monitoring with early warnings benefit hospital patients

Recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2024/01/061082
• Lead Sponsor: Turtle Shell Technologies Pvt Ltd

Brief Summary

Recognizing and responding to signs of worsening health in hospital wards is a common problem. Due to the large number of patients, healthcare providers can only check vital signs every few hours, which can result in missed signs of deterioration. Digital adoption and remote patient monitoring have become important in healthcare, but continuous monitoring is not widely used outside critical care settings. Implementing continuous monitoring in general wards can lead to alarm fatigue and high false alarm rates, burdening caregivers and potentially putting patients at risk.

Dozee, developed by Turtle Shell Technologies (TST) Private Limited, is a validated system for remote patient monitoring. It uses non-invasive sensors to continuously monitor heart rate, respiration rate, blood pressure, ECG rhythm, temperature and SpO2. Dozee goes beyond traditional patient monitors by delivering EWS Alerts based on customized algorithms using the above vital values. These alerts consider the overall patient condition, reducing excessive alerts and alarm fatigue. This clinical study aims to assess the impact of Dozee’s  EWS Alerts on patients’ clinical outcomes. The study will be conducted in two phases. In the first phase, the correlation between Dozee’s EWS Alerts, on patient outcomes will be examined. No clinical actions will be taken based on the alerts during this phase and the present standard of care will be followed in the study wards. In the second phase, interventions will be taken based on Dozee’s  Alerts, and the outcomes will be documented. A comparative analysis between the two phases will provide insights into the impact of Dozee on healthcare delivery and patient outcomes.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-21
• Study Start: 2024-10-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Adult (18 years old and more) ward patient admitted in one of the identified study wards 2.
• Weight between 40kg-120kgs 3.
• They or legal representative are able and willing to provide written informed consent.

Exclusion Criteria

• Admitted for observation period of more than 4 hours 2.
• Weight below 40 kgs and above 120 kgs 3.
• Have any condition that could interfere with the subjects ability to lie flat or stable on the bed 4.
• Needs the use of equipments whose operation can interfere with Dozee signal 5.
• Patient not giving or unable to give consent 6.
• Pregnant 7.
• Patients with pacemakers.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enhanced Patient safety, Optimised health economics	At baseline

Secondary Outcome Measures

Name	Time	Method
Ease of usage	At baseline

Trial Locations

Locations (1)

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Christian Medical College

🇮🇳Vellore, TAMIL NADU, India

Dr Aby Abraham

Principal investigator

04162282352

aby@cmcvellore.ac.in