Non-Invasive Cardiac Output Monitor in Children
Condition: Cardiac Output, Low; Pediatric
MeSH terms: Cardiac Output, Low
Study type: Observational

Summary: 
      This study will be the first of several studies that establish the value of measuring fluid
      responsiveness in children undergoing general anesthesia. The first study in this series will
      determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in
      normal children before and after passive leg raising, predicts changes in stroke volume,
      cardiac output, and blood pressure during the early stages of anesthesia. A second study will
      determine if early treatment of the fluid responsiveness will prevent the decline in blood
      pressure that accompanies general anesthesia. If the NICOM monitor permits accurate
      prediction in normal patients, future studies of pediatric patients undergoing major surgery
      would be indicated.

      The investigators would like to add 25 additional patients who will have the NICOM
      assessments performed in the pre operative area - Pre anesthesia. General anesthesia may
      alter the results of the NICOM assessments. The investigators will use these 25 subjects to
      serve as a comparison/control group.
    

Detailed description: 
      Eligible patients will be identified from the surgery schedule and will be contacted by a
      research team member via phone ahead of their surgery date to inform them of the research
      study. This call will allow the research team member to answer questions and establish the
      subject's interest in participation. If interested, or not able to be contacted by phone,
      patient/family will be approached in the pre-operative area or other private hospital
      setting. He/she and their parent(s) will have ample time to read the consent and ask any
      questions regarding the study.

      If the subject and his/her parent(s) agree to participate, all standard techniques for
      general anesthesia compatible with the particular surgical procedure will be employed.
      Clinical decisions concerning the subject's perioperative care will be made by the
      anesthesiologist of record.

      Cardiac output will be measured with the NICOM cardiac output monitor. The NICOM is a
      non-invasive monitor using bioreactance, a proprietary technique developed by Cheetah Medical
      that utilizes delay time shifts to measure stroke volume when an alternating current is
      passed through the thorax. It requires the placement of four surface electrodes (similar to
      ECG electrodes) above and below the heart on each side of the patient's chest.

      This study will measure cardiac output, stroke volume, and fluid responsiveness (increase in
      stroke volume > 10%) obtained via passive leg elevation immediately after induction of
      anesthesia. Adult studies have demonstrated that fifty percent of fasted patients are fluid
      responsive. The investigators seek to determine the incidence on children.

      All decisions concerning clinical care of the subject during the perioperative period will
      made by the anesthesiologist of record in accordance with accepted standard of care.

        1. The NICOM® electrodes will be applied in proper position in the pre-op area. In pre-op,
           baseline and passive leg measurements will be recorded using the NICOM®. Electrodes will
           remain in place and will again be used during the OR NICOM® measurements.

        2. Standard physiologic monitors will be used: non-invasive blood pressure, ECG, pulse
           oximeter, capnograph (end-tidal carbon dioxide), BIS (bispectral analsysis/depth of
           anesthesia).

        3. Induction of anesthesia to be determined by the anesthesiologist of record. May be
           either inhalation or intravenous.

        4. Measurements recorded after application of NICOM electrodes include blood pressure,
           heart rate, end-tidal carbon dioxide, arterial oxygen saturation, BIS level, stroke
           volume, cardiac output.

        5. After measurement of baseline cardiorespiratory parameters, passive leg elevation to 45
           degrees will be performed.

        6. Cardiorespiratory measurements describe in section d will be repeated after passive leg
           elevation.

        7. Cardiorespiratory parameters will be measured during the next 60 minutes of anesthesia.
           This information will be used to determine whether fluid responsive patients require
           additional intravenous fluids or vasoactive drugs during the course of anesthesia.

      The same procedures listed above will be performed Pre-anesthesia in the Pre operative area,
      while the subject is fully awake.

      General anesthesia may alter the results of the NICOM procedures. The investigators will add
      25 patients who will be evaluated with the study procedures pre anesthesia as a
      control/comparison group.
    

Intervention name(s): NICOM by Cheetah Medical
Intervention type(s): Device
Intervention description(s): Observational measurement, Cardiac Output, Pre- and Post Anesthesia
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy 10 to 17 years old