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Novel Continuous Esophageal Pressure Monitoring Catheter with Feeding Tube

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HD090814-01A1
Agency Tracking Number: R43HD090814
Amount: $224,923.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-12
Award End Date (Contract End Date): 2019-08-31
Small Business Information
W4272 455TH AVE, Ellsworth, WI, 54011-5807
DUNS: 079244469
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 JULIE LUNDSTROM
 (651) 271-9531
 jlundstrom@rushriverresearch.com
Business Contact
 JULIE LUNDSTROM
Phone: (651) 271-9531
Email: jlundstrom@rushriverresearch.com
Research Institution
N/A
Abstract
PROJECT SUMMARY ABSTRACT Over US adults and children are on mechanical ventilators in intensive care units each year While major advancements in ventilator devices have improved outcomes for critically ill patients current ventilator practice is predominately based on measurements of airway pressure The more relevant pressure particularly to determine if mechanical ventilation is causing harm is the pressure across the alveoli or transpulmonary pressure During controlled ventilation accurate measurements of transpulmonary pressure can help adjust ventilator settings to minimize ventilator induced lung injury which leads to multiple organ failure inability to wean from mechanical ventilation and death Accurate transpulmonary pressure measurements require an estimate of pleural pressure which is not feasible to measure directly in humans Esophageal pressure is an accepted surrogate for pleural pressure with esophageal balloon catheters serving as the most commonly used method for measurement Recent research in both adults and children highlight many potential benefits of measuring esophageal pressure but these measurements are often limited to research centers that have developed expertise in using esophageal balloon catheters Balloon catheters have many limitations related to placement dependence on balloon filing volume cardiac artifact and patient size and position Hypothesis We hypothesize an easier to use more accurate and more stable pressure sensing catheter can be made using a fiber optic pressure sensor integrated with a feeding tube Providing an easy to use stable and accurate pressure sensing catheter that can remain in the patient for weeks at a time and be used for feeding will increase the number of patients who will benefit from esophageal pressure measurements Specific Aims Rush River Research RRR Corporation proposes to develop a novel catheter to provide simultaneous esophageal pressure esophageal temperature and feeding for use in ventilated patients In aim we will develop prototype catheters with integrated pressure sensor temperature sensor and feeding tube which meet FDA standards for mechanical efficiency In aim we will evaluate the catheter s accuracy in simulated pleural pressure measurement and determine the frequency with which ex vivo calibration is needed using a laboratory model Aim will test the catheter s responsiveness to real changes in pleural pressure and determine if it is robust against common sources of artifact using an animal model Team RRR has assembled a highly qualified team of critical care researchers and a major OEM catheter developer and manufacturer to achieve these goals PROJECT NARRATIVE There is growing research showing the importance of measuring esophageal pressure as a surrogate for pleural pressure for patients on mechanical ventilators The most common measurement method uses a balloon catheter whose accuracy can vary based on patient anatomy balloon position balloon inflation and the presence of other tubes in the esophagus A new combination catheter is needed to provide more accurate esophageal pressure measurements which is easy to use and has an incorporated feeding tube and temperature sensor

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

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