A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
Condition: Children Receiving General Anesthesia
Study type: Observational

Summary: 
      Traditionally cardiac output has been estimated with thermodilution. Recently a new
      non-invasive device has been approved by the FDA for use in children of all ages including
      neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous
      physiologic data for all enrolled children by transferring the data from the investigators
      computerized anesthesia records to Excel spreadsheets and to correlate adverse events across
      monitoring devices.

      Secondary outcomes: To determine if the device provides meaningful data in terms of an early
      warning of decreased cardiac output in specific subgroups of children undergoing surgery and
      anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those
      undergoing procedures with expected blood loss, those undergoing laparoscopic procedures
      where gas insufflation may impede venous return to the heart.
    

Detailed description: 
      All children undergoing both elective and emergent surgery or GI endoscopy evaluation will be
      candidates for study. Since this is an FDA approved monitor that is approved across all age
      groups and since this is an additional monitor over those routinely used in the operating
      room and since it is noninvasive (4 EKG leads) verbal consent documented in the record has
      been approved by the IRB.

      After informed verbal consent, either the research coordinator or a study physician will
      populate the cardiac output device with the child's age, weight, gender and height. For older
      children the required 4 EKG electrodes will be applied prior to induction of anesthesia (2 on
      the left side of the neck and 2 on the left chest at the level of the sternal depression; for
      neonates and infants one electrode can be applied to the forehead and the other to a thigh if
      application space is a problem). For children who are not able to be cooperative, as with
      most of our monitors the electrodes will be placed after induction of general anesthesia. An
      automated anesthesia record will continuously record heart rate, respiratory rate, oxygen
      saturation, systolic and diastolic pressures. The monitor will be set to perform these
      measurements every 1 minute. New software has been written that enables us to interface the
      cardiac output device with our automated anesthesia record. Thus the data from the cardiac
      output device will be inserted on the anesthesia record at approximate 1 minute intervals in
      real time. The data from the anesthesia records will later be downloaded as a unit to Excel
      spread sheets for later analysis. All demographic data will also be downloaded (age, weight,
      ASA physical status,surgical procedure) as well as blood loss and blood and fluid
      administered as well as drugs,significant intraoperative events, and the timing of events as
      they evolve. All data will be entered on a Partners password protected computer. Initially
      the patient's medical record number which links us to the electronic anesthesia record will
      be recorded as this allows us to download the data. Patient names will not be downloaded.
      Once the data set is completed,analyzed and locked, the medical record number will be removed
      so that no identifiers will remain. The data will not be shared with any other institution.
      Only deidentified data will remain on the final data base
    

Intervention name(s): cardiac monitor
Intervention type(s): Device
Intervention description(s): All children receive the same intervention which is the application of the 4 ekg electrodes
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        neonates to teenagers
      
Keywords: adverse events; adverse cardiovascular events; early warning