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OpenTrials
Completed

NCT Number: NCT06270953

Non-invasive Monitoring: Impact on Patient Management and Outcomes

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.

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Key information

Age range

18 month–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oak Village Healthcare

Lake Jackson, Texas, 77566, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dozee Pro NX

Device

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

Primary outcomes

  1. Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),

    Time frame: 3 months

Secondary outcomes

  1. HCP experience response data

    Time frame: 3 Months

  2. Care pathway mapping

    Time frame: 3 Months

Sponsors and collaborators

Lead sponsor

Turtle Shell Technologies Pvt. Ltd.

Industry

Registry information

Official study title

Impact of Non-invasive Continuous Patient Monitoring System on Patient Management and Health Outcomes

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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