For infants born with a single ventricle heart, the Norwood Stage I operation is a life-saving procedure. This procedure is the first in a three-step pathway that begins to correct a newborn?s circulation by providing flow to both the systemic circulation and pulmonary circulation from the one ventricle. After the surgery however, there is no way to continually monitor the flow that is going to the pulmonary and systemic circulations (cardiac output) to be sure each has adequate flow. The long term objective of this project is to provide the first implantable wireless blood flow monitor for patients after Norwood Stage I Single Ventricle Palliation surgery. The perivascular sensor used for measuring flow/cardiac output will be placed on the right ventricle-pulmonary artery shunt that is created during the surgery. Unlike existing technology, this will be able to provide continuous measurements to identify changes in cardiac output after surgery. This will allow for timely therapy for the patient. Additionally intermittent measurements using an injection of saline with provide information regarding the distribution of blood flow in the heart. Based on preliminary work and the prototype algorithms, this project will begin by developing a sensor system capable of transmitting and recording changes in the ultrasound velocity of blood. The meter component of the system will be made to receive these changes and programmed to automatically produce and display the flow measurements. Animal studies will then be performed on 6 piglets at the Animal Research Facility at Children?s National Medical Center in order to validate the Qp/Qs calculations in a single ventricle animal model. Phase I will end with a preliminary clinical study at Children?s National Medical Center. 4-6 patients will be recruited for a feasibility test of the sensor placement and dilution calculations.
Project Terms: Acute; Algorithms; Animal Model; Animals; ascending aorta; base; biomaterial compatibility; Blood; Blood Circulation; Blood flow; Cardiac Output; Cardiac Surgery procedures; Cessation of life; Chest; Child; Clinical; clinical development; Clinical Research; Common Ventricle; Computer software; cost; Dangerousness; Data; Development; Ensure; Heart; Heart Ventricle; high risk; Home environment; Hospitals; Hypoplastic Left Heart Syndrome; IACUC; Infant; Injections; Institutional Review Boards; Intensive Care Units; intravenous injection; Laboratory Animal Production and Facilities; Length of Stay; Life; Low Cardiac Output; Lung; Mathematics; Measurement; Measures; Medical center; meter; Monitor; Morbidity - disease rate; mortality; Newborn Infant; Normal saline; Operating Rooms; operation; Operative Surgical Procedures; Output; palliation; Parents; Pathway interactions; Patient Monitoring; Patients; Perioperative; Phase; Physicians; Procedures; Property; prototype; Pulmonary artery structure; Pulmonary Circulation; recruit; Right ventricular structure; safety testing; Saline; Savings; sensor; Series; Shunt Device; System; Technology; Testing; Time; tool; Transplantation; Ultrasonography; United States; Validation; Wireless Technology; Work;
