NIRS Guidance Trail in Children's Heart Surgery
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

Summary: 
      Heart surgery in young children involves some risks. This study looks at a new type of
      monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to
      measure if enough blood reaches vital organs in the body. The investigators goal is to see if
      this shows problems developing sooner than usual. The investigators do not know at this time
      if they can improve the blood supply to the vital organs. The investigators main aim is to
      see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug
      Administration (FDA).

      The investigators will also follow the progress of recovery after surgery in the Cardiac
      Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome
      for children.
    

Detailed description: 
      The NIRS monitor will record information from the patient until he/she has been in the CICU
      for about 24 hours. The monitoring consists of small sticky pads placed on the child's
      forehead and trunk. These work like the pulse oximeter (oxygen monitor) that has been used
      for for the child already, but have a more sensitive detector.

      NIRS data will be recorded in the operating room and in the CICU for all babies in the study.
      The NIRS values can be seen by the surgical and anesthesia teams in the operating room for
      all babies in the study. Once the patient is in the CICU, the NIRS values will be visible to
      the CICU team only if he/she is assigned to the intervention group. If he/she is assigned to
      the control group the NIRS values will not be visible to the CICU team. Currently, use of the
      NIRS monitor is not standard care in the CICU.

      For half of the children in the study (intervention group) the team will follow a carefully
      designed plan on how to react to any changes seen. For the other half of the children
      (control group) the team will respond to any changes seen according to their standard
      practice. For the control group NIRS monitoring will occur in the operating room but not in
      the CICU. By using two groups, the investigators can compare the NIRS recordings. In this way
      the investigators will find out if blood supply to the tissues is altered.

      No standard monitoring or treatments will be withheld from the patient.

      Some extra urine tests will be taken in the 24 hours following surgery. They will be taken
      from the catheter inserted into the patient's bladder, as is standard for all heart surgery.
      No genetic tests will be done.

      The patient will have usual medical care following the 24 hours of the study. The
      investigators will use the hospital's electronic notes to collect further information. This
      will include medications, routine labs and vital signs. The investigators may also call the
      family 60 days after surgery with a few simple questions about the patient's current state of
      health.
    

Intervention name(s): NIRS based management; Control
Intervention type(s): Other; Other
Intervention description(s): Check NIRS, mechanics, muscle relaxation, hemodynamics, ventilation, hematocrit, surgical repair
Deepen anesthesia with volatile or intravenous agent.
Consider Extra-Corporeal Membrane Oxygenation (ECMO).; During the Control Arm, the medical team completes all tasks as clinically necessary and in the best medical interest of the patient, without any input from the study procedures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment