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RT Assistant - handheld patient safety tool for mechanical ventilation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL146012-02A1
Agency Tracking Number: R44HL146012
Amount: $1,397,757.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA20-262
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-06-15
Award End Date (Contract End Date): 2023-05-31
Small Business Information
107 SW 140TH TER STE 1
Newberry, FL 32669-3367
United States
DUNS: 176698624
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (352) 378-4899
Business Contact
Phone: (352) 378-4899
Research Institution

Respiratory Therapists (RTs) are increasingly tasked to improve the quality of care provided for their patients
on mechanical ventilation while controlling cost amidst a high workload. Challenges for the RTs include
maintaining continuous awareness of patient-ventilator interactions, assuring compliance with best practice
protocols, and providing efficient communication during shift changes. While new technology has been recently
introduced to improve medical record documentation, there is a scarcity of innovative electronic tools that can
improve compliance with best practices and communications in respiratory care.
In Phase I of the grant we successfully built and evaluated a fully-functional prototype system called RT
Assistant that provides continuous remote monitoring of ventilated patients. The device provides real time
management guidelines, guidance on patient safety and best clinical practices, and a standardized hand-off
communication tool. The Phase I prototype was designed to evaluate the feasibility of the tool and its
integration into an RT's workflow. Phase II effort will add functionality, improve data security, increase usability,
and allow for customized user interfaces for each hospital or unit. The Phase II system will facilitate
commercialization and will be tested in 3 clinical trials at 3 different hospitals. RT Assistant will serve as a
platform for future modular upgrades that will provide clinical decision support (CDS) tailored for respiratory
care. In Phase II, we propose two specific aims.
Aim 1 – Productize the RT Assistant system
To address usability and commercialization concerns, this aim will address three categories of improvements
to RT Assistant. First, implement and validate appropriate data security and IT requirements in order to be
allowed to operate safely in a healthcare environment. Second, increase functionality by adding an additional
oxygenation CPG, support low acuity ventilation, and management features that support departmental quality
assessment. Third, increase ease of use by allowing customization of the system for different hospitals and
ICUs and enable use on different platforms.
Aim 2 – Evaluate effectiveness of RT Assistant in multi-center clinical trial
To evaluate the effectiveness of the system in different environments, we will evaluate the system in two ICUs
from two different hospitals. Baseline data will be collected for 1 month and then data will be collected while
RTs use the RT Assistant for 1 month. Statistical analyses of pre- and post-intervention data includes change
in time patients are outside the CPGs, quality of shift reports, and RT satisfaction scores while using the
After completion of this Phase II grant, we will have created a secure, inexpensive, intuitive, highly functional
system proven to: increase compliance with CPGs, improve shift report communication, and enhance
situational awareness, resulting in improved patient care and reduced medical errors. The clinical results will
provide data that will enable early adopter sales for the RT Assistant system.

* Information listed above is at the time of submission. *

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