Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study). The LUCID Device is Used in the Treatment of Ischemic Brain Reperfusion Injury Caused by Cardiac Arrest in Pediatric Patients.

LUCID is a device designed to deliver therapeutic NIR light (750 nm and 950 nm) to the brain of infants to provide neuroprotection following cardiac arrest and resuscitation. LUCID consists of two distinct parts: (1)Human interface, and (2) Light source and user interface. The human interface will deliver therapeutic NIR light directly to the infant's head. The light delivery areas distribute the light to ensure uniform distribution, dose, and safety. LUCID is compatible with EEG monitoring and protective eye covering. It is an appropriate size and weight for clinical use, and capable of battery operation which will allow patient transport and incorporation into seamless clinical workflow. The light source and user interface contain laser diodes producing the therapeutic wavelengths with thermoelectric and air cooling to prolong the lifetime of the diodes and provide temperature control. LUCID also contains a user interface/control panel. Power supply is via standard power outlet. The LUCID control module is equipped with a simple, user-friendly interface for initiating the treatment as well as system feedback to ensure proper function of the device and therapeutic delivery. The system has a main power switch located on the front of the device which engages power to the diode subassemblies, enables system thermoregulation components, and runs a quick system self-check. The healthcare provider will place and secure the cap on the infant's head and connect the light source to the human interface. Once the cap has been properly connected to the light source, the connection indicator will illuminate, signaling that the treatment is ready to initiate. Once treatment is initiated by the user, the user interface will monitor contact, light, and temperature sensors in the cap to ensure the device is operating within designated safe and effective treatment parameters. If abnormalities are detected, the unit will disengage treatment. Clinician oversight is required during the treatment period to monitor the patient and system. Normal system operation shows a visible treatment countdown timer on the front panel to document a full 4-hour treatment. The system logs treatment duration, date and time of treatment for documentation of therapeutic delivery and system performance. The system will automatically terminate therapeutic NIR light at the end of the 2-hour treatment, and the system will notify the user when treatment has stopped. Errors in the system that would initiate safety shutdown include loss of LDU contact with the patient's skin, light loss or excess at the light delivery patient interface, system overheating, diode failure, or active system cooling failure. The user interface will indicate treatment interruption with an error LED and audio indicator, along with documentation in the run log including the error code with time to document the duration of treatment interruption and the dose the patient received. To provide eye protection during LUCID treatment, eye masks such as the EyeMax-2 or NeoShades (routinely used in infants undergoing phototherapy for hyperbilirubinemia) will be placed on the infant. Eyewear for the clinician is recommended but not required. The LUCID system consists of 2 primary components: 1. Lightbox: This multiple use component generates the 750 (+/- 10) and 940 (+/- 10) nanometer light delivered to the patient via a fiberoptic cable (interface cable) connected to the cap. The Lightbox includes the user interface and control electronics that ensure the specific amount of light is delivered and all safety measures are being performed. 2. Cap: This single use device employs light guides that diffuse and direct the light into the patient's head during treatment. The Cap includes silicone waveguides (Light Delivery Units - LDU's) that direct therapeutic light into the patient and returns specific measurements (GOOD CONTACT indicator, temperature, light levels) to the Lightbox.