Actuated, Low-Stress, Endotracheal Tube Cleaner to Improve Neonate Lung Function

Information

  • Research Project
  • 9206507
  • ApplicationId
    9206507
  • Core Project Number
    R44HD074310
  • Full Project Number
    5R44HD074310-03
  • Serial Number
    074310
  • FOA Number
    PAR-13-090
  • Sub Project Id
  • Project Start Date
    10/1/2012 - 11 years ago
  • Project End Date
    1/31/2018 - 6 years ago
  • Program Officer Name
    RAJU, TONSE N.
  • Budget Start Date
    2/1/2017 - 7 years ago
  • Budget End Date
    1/31/2018 - 6 years ago
  • Fiscal Year
    2017
  • Support Year
    03
  • Suffix
  • Award Notice Date
    1/26/2017 - 7 years ago
Organizations

Actuated, Low-Stress, Endotracheal Tube Cleaner to Improve Neonate Lung Function

? DESCRIPTION (provided by applicant): This Phase II SBIR finalizes development and clinically tests Neo ET-Clear - an Actuated, Low-Stress, Endotracheal Tube (ETT) Cleaner to Improve Neonate Lung Function. Neo ET-Clear suctions mucus from 2.5 mm diameter neonatal endotracheal tubes with significantly reduced deleterious impact on lung function and mechanics, as compared to current methods, including Closed Suction Systems. Public Health Problem: ETTs are placed in 107,000 neonatal patients annually in the U.S. Intubation is particularly common in NICUs in tertiary care referral sites, which see a high number of complicated premature neonates, and intubation rates as high as 60%. The ETT in the respiratory tract stimulates secretions and interferes with the patient's ability to expectorate. T remove secretions, ETTs are regularly aspirated with suction catheters (every 3-6 hours). The normal suctioning procedure is extremely uncomfortable and stressful to the patient. Such pain and distress, when occurring in neonates, can affect brain growth and lead to long-term developmental delays. Immediate risks associated with standard suctioning include loss of lung volume and compliance, desaturation/hypoxia (low blood oxygen), decreased heart rate, and changes in cerebral blood flow/oxygenation. Furthermore, standard suction catheters can push secretion material, possibly containing bacteria, into the respiratory tract, increasing the risk o lung infection. Potential long-term risks of repeated suctioning include chronic lung disease from occult atelectasis and retinopathy of prematurity due to large fluctuations in blood oxygen. A device is needed for clearing neonatal ETTs that reduces the harmful side-effects of standard suctioning methods on short and long-term patient health, and on lung function. Neo ET-Clear is an actuated closed suction system designed to safely and effectively suction neonatal and pediatric patients on mechanical ventilation. The Neo ET-Clear Suction Stem incorporates a controlled gentle vibration with internal irrigation that facilitates mucus removal. The Stem is inserted in and out of the patient's ETT - similar to standard closed Suction Catheter. The Phase I project met all Specific Aims, demonstrating that Neo ET-Clear dramatically reduced effects on test-model lung mechanics (2-3x better maintenance of inspired Tidal Volume, and PEEP loss of only 10% compared to 70%) during closed suctioning of 2.5 mm ETTs, while achieving equal mucus removal and tidal volume restoration compared to standard 5 Fr Closed Suction Catheters. Feedback from practicing NICU clinicians was extremely enthusiastic. Phase II - Hypothesis: Neo ET-Clear is Safe for use in Neonatal Patients and Reduces the Negative Impact of Suctioning on Blood Oxygen, Lung Mechanics, and Patient Distress. Aim 1 - Incorporation and validation of design and safety features into Neo ET-Clear does not impact beneficial suctioning efficiency results. Aim 2 - Demonstrate Safety and Improved Physiologic Outcomes with Neo ET-Clear through Pre-Clinical Testing. Aim 3 - Pilot Human Clinical Evaluation (Children's Hospital of Philadelphia, n=10).

IC Name
EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
  • Activity
    R44
  • Administering IC
    HD
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    667701
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    865
  • Ed Inst. Type
  • Funding ICs
    NICHD:667701\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    ACTUATED MEDICAL, INC.
  • Organization Department
  • Organization DUNS
    791379030
  • Organization City
    BELLEFONTE
  • Organization State
    PA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    168238445
  • Organization District
    UNITED STATES