A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor

NCT ID: NCT01678066

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Anesthesiology; Pediatrics; General Surgery; Orthopedics; General Anesthesia; Cardiac Output

Keywords

Noninvasive cardiac output.; Pediatrics.

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral cardiac output

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.

Bilateral cardiac output

Intervention Type: DEVICE

Interventions

Bilateral cardiac output

Intervention Type: DEVICE

Other Intervention Names

Cardiotronic ICON non-invasive cardiac output monitor

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Thomas Anthony Anderson

Assistant in Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas A Anderson, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Thomas A Anderson, PhD, MD

Role: CONTACT

Phone: 617-724-7247

Email: tanderson9@partners.org

Charles J Cote, MD

Role: CONTACT

Phone: 617-724-2250

Email: cjcote@partners.org

Facility Contacts

Thomas A Anderson, PhD, MD

Role: primary

Charles J Cote, MD

Role: backup

References

Suttner S, Schollhorn T, Boldt J, Mayer J, Rohm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. doi: 10.1007/s00134-006-0409-x. Epub 2006 Oct 13.

Reference Type: BACKGROUND

PMID: 17039348 (View on PubMed)

Norozi K, Beck C, Osthaus WA, Wille I, Wessel A, Bertram H. Electrical velocimetry for measuring cardiac output in children with congenital heart disease. Br J Anaesth. 2008 Jan;100(1):88-94. doi: 10.1093/bja/aem320. Epub 2007 Nov 16.

Reference Type: BACKGROUND

PMID: 18024954 (View on PubMed)

Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schalte G. Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9. doi: 10.1111/j.1399-6576.2007.01445.x.

Reference Type: BACKGROUND

PMID: 17944633 (View on PubMed)

Other Identifiers

2012P001561

Identifier Type: -

Identifier Source: org_study_id