Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05380102
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2022-05-11
Brief Title:
Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS
Sponsor:
Turtle Shell Technologies Pvt Ltd
Organization:
Turtle Shell Technologies Pvt Ltd
Study Overview
Official Title:
Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Dozee VS device developed by Turtle Shell Technologies Pvt Ltd is a contactless continuous vital parameters monitoring system It is designed for continuous and contactless measurement of Heart Rate HR and Respiratory Rate RR The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions upper respiratory tract activity and body movements This data is then analyzed by a proprietary algorithm and the values of the vital parameters - Heart Rate HR and Respiratory Rate RR are generated The captured vital parameters can be accessed remotely via a dashboard which can be accessed on any web browser and a smartphone application The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body It consists of the following sub - units Contactless sensor sheet Dozee Pod with power cord 5 Volt Universal Serial Bus USB Power Adapter Health data compute server and Web DashboardMobile App This provides a more comfortable solution for long-term continuous patient monitoring Continuous monitoring of peoples vital signs in particular Heart Rate HR and Respiratory Rate RR may provide a mechanism to alert doctors or nurses of clinical deterioration Monitoring peoples vital signs outside an ICU often relies on nursing staff conducting checks at set intervals The device can reduce the workload for nursing staff in non-ICU wards
Detailed Description:
Dozee VS device is intended for the contactless continuous monitoring of vital parameters Heart Rate and Respiratory Rate and screening for abnormal changes in these parameters The device is intended to be used to monitor individualspatients greater than eighteen 18 years of age 40 kg weight 120 kg and can measure their vital signs during sleep and resting state The data can be viewed on the dashboard exported and even be directly transferred to the in-house hospital management software This protocol aims at verifying the safety and effectiveness of the investigational device in a general-care clinical environment A similar predicate can be found in the FDA-cleared EarlySense 20 K131379 developed by EarlySense Limited which shall be used as the predicate device The device also uses the concept of ballistocardiography and employs piezoelectric sensors to create a contact-less continuous monitoring system which monitors the same vital parameters It has been sold in over 20 hospitals in United Sates since 2013 with no recalls or adverse events reported According to publicly available clinical results this system has shown an 86 reduction in Code Blue events and a 45 reduction in Length of Stay LoS in the Intensive Care Unit ICU for patients coming from the medicalsurgical unit The technology employed and the indications for use for the EarlySense device is very similar to the Dozee VS device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20221665 | OTHER | WCG IRB | None |