A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 8 |
| Updated: | 4/2/2016 |
| Start Date: | September 2012 |
| End Date: | February 2013 |
| Contact: | Thomas A Anderson, PhD, MD |
| Email: | tanderson9@partners.org |
| Phone: | 617-724-7247 |
A Prospective Study to Bilaterally Compare a New FDA-Approved Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia
Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate
information when placed on a patient's Right or Left side.
Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac
output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The
FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the
manufacturer in pediatric and adult patients with leads placed on the left side. However,
sometimes the surgical site and/or patient position precludes placement of the monitor leads
on the left side. In such situations it would be useful to know whether placement of the
monitor's leads on a patient's right side gives accurate cardiac output data. We will
prospectively collect, and compare, simultaneous physiologic data for all enrolled children
using two monitors, one on the patient's right side and one on the patient's left side.
information when placed on a patient's Right or Left side.
Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac
output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The
FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the
manufacturer in pediatric and adult patients with leads placed on the left side. However,
sometimes the surgical site and/or patient position precludes placement of the monitor leads
on the left side. In such situations it would be useful to know whether placement of the
monitor's leads on a patient's right side gives accurate cardiac output data. We will
prospectively collect, and compare, simultaneous physiologic data for all enrolled children
using two monitors, one on the patient's right side and one on the patient's left side.
Traditionally cardiac output has been estimated with thermodilution, Fick oxygen consumption
or with echocardiography. Other non-invasive techniques such as analysis of arterial wave
forms and measurement of expired carbon dioxide have been attempted but with variable
success. Recently a new device (Cardiotronic® EC™) has been approved by the FDA for use in
children of all ages including neonates. Electrical cardiometry is a new method which can
continuously estimate stroke volume and left ventricular outflow to calculate cardiac
output, calculate cardiac index, as well as a variety of other parameters through
quantitation of changes in impedance associated with changes in the orientation of red blood
cells. During diastole red cells are organized chaotically but during systole they assume a
position parallel to the direction of blood flow. Thus thoracic electrical bioimpedance
relate to changes in thoracic aortic blood flow and through the use of refined algorithms
non-invasive measurement of cardiac output is achieved.
The height (cm), gender, weight (kg) and age of the patient are entered into the hand-held
device. Eight electrodes are applied to the neck and chest at specified locations, four per
device. The device records the heart rate and averages cardiac output every 10-60 heartbeats
again depending upon how the device is configured.
This is a prospective, non-randomized study to collect data from two noninvasive
FDA-approved cardiac output monitors simultaneously in pediatric patients under general
anesthesia in the operating room from age 1 month old to 8 years old with all types of
medical conditions. We will enroll 50 male and female pediatric patients who are having
lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads
placed on the patients do not interfere with the surgical site or patient positioning.
or with echocardiography. Other non-invasive techniques such as analysis of arterial wave
forms and measurement of expired carbon dioxide have been attempted but with variable
success. Recently a new device (Cardiotronic® EC™) has been approved by the FDA for use in
children of all ages including neonates. Electrical cardiometry is a new method which can
continuously estimate stroke volume and left ventricular outflow to calculate cardiac
output, calculate cardiac index, as well as a variety of other parameters through
quantitation of changes in impedance associated with changes in the orientation of red blood
cells. During diastole red cells are organized chaotically but during systole they assume a
position parallel to the direction of blood flow. Thus thoracic electrical bioimpedance
relate to changes in thoracic aortic blood flow and through the use of refined algorithms
non-invasive measurement of cardiac output is achieved.
The height (cm), gender, weight (kg) and age of the patient are entered into the hand-held
device. Eight electrodes are applied to the neck and chest at specified locations, four per
device. The device records the heart rate and averages cardiac output every 10-60 heartbeats
again depending upon how the device is configured.
This is a prospective, non-randomized study to collect data from two noninvasive
FDA-approved cardiac output monitors simultaneously in pediatric patients under general
anesthesia in the operating room from age 1 month old to 8 years old with all types of
medical conditions. We will enroll 50 male and female pediatric patients who are having
lower abdominal and lower extremity surgery in this study so that the additional 8 EKG leads
placed on the patients do not interfere with the surgical site or patient positioning.
Inclusion Criteria:
- 1 month old to 8 years old.
- Lower abdominal or lower extremity surgery.
Exclusion Criteria:
- Less than 1 month old.
- Greater than 8 years old.
- Patients undergoing upper abdominal, thoracic, upper extremity, or head/neck surgery.
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