Non-invasive Monitoring: Impact on Patient Management and Outcomes

NCT ID: NCT06270953

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2024-06-30

Brief Summary

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.

Detailed 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.

Conditions

No Specific Medical Conditions or Disease States

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Obervational group

Patients admitted in the SNF facility during the study period

Dozee Pro NX

Intervention Type: DEVICE

Dozee Pro NX to measure Heart Rate, Respiratory Rate, SPO2 and movements

Control group

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

No interventions assigned to this group

Interventions

Dozee Pro NX

Dozee Pro NX to measure Heart Rate, Respiratory Rate, SPO2 and movements

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turtle Shell Technologies Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Darthard, LNFA

Role: PRINCIPAL_INVESTIGATOR

Oak Village Healthcare

Locations

Oak Village Healthcare

Lake Jackson, Texas, United States

Countries

United States

Other Identifiers

DZ_NX_US

Identifier Type: -

Identifier Source: org_study_id