Non-invasive Monitoring: Impact on Patient Management and Outcomes

Turtle Shell Technologies

Status: Enrolling

Conditions: No Specific Medical Conditions or Disease States

Treatments: Device: Dozee Pro NX

Study type: Observational

Funder types: Industry

Identifiers

NCT06270953

DZ_NX_US

Details and patient eligibility

About

Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.

Full description

In skilled nursing facilities (SNFs) and assisted living facilities (ALFs), managing patient health presents considerable hurdles in accurately identifying and responding to deteriorating conditions. The intricacies of care within these settings are compounded by a high patient-to-healthcare provider ratio, often leading to infrequent vital sign checks with significant time gaps between assessments. This monitoring gap may result in overlooking early signs of health decline, potentially causing adverse patient outcomes. A February 2014 report by the Office of Inspector General (OIG) underscored this issue, revealing that around 22% of Medicare beneficiaries experienced adverse events during their stays in SNFs, with an additional 11% facing temporary harm events. Notably, 59% of these incidents were considered preventable, largely due to insufficient patient monitoring, care delays, and substandard treatment. In response to these challenges, Turtle Shell Technologies (TST) Private Limited has developed Dozee Pro NX, an innovative system tailored to improve patient monitoring in these healthcare settings. This system employs non-invasive sensors to continuously monitor crucial parameters such as heart rate, respiration rate, blood pressure, temperature, and SpO2. Distinguished from traditional patient monitoring devices, Dozee Pro Nx offers advanced functionalities, including customizable notifications to alert healthcare providers of vital sign deterioration, thereby enabling prompt intervention. The primary objective of this clinical study is to evaluate the potential impact of the Dozee Pro Nx system on patient outcomes, healthcare practitioner efficiency, and overall healthcare costs. This investigation aims to ascertain whether the implementation of this advanced monitoring technology can effectively address the identified gaps in patient care within SNFs and ALFs, ultimately leading to improved health outcomes and enhanced care delivery.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 months to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older.
• Weight between 40kg-120kgs

Exclusion criteria

• Terminal illness with a life expectancy of less than 1 month.
• Have any condition that could interfere with the subject's ability to lie flat or stable on the bed
• Needs the use of equipment whose operation can interfere with Investigation System operations
• Patients planned to be transferred from the facility within 72 hours
• Prisoners
• Pregnant

Trial design

150 participants in 2 patient groups

Obervational group

Description:

Patients admitted in the SNF facility during the study period

Treatment:

Device: Dozee Pro NX

Control group

Description:

Historical control with patients admitted in the SNF before the study period