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

NCT01678066 | Unknown

• 1 other identifier: 2012P001561
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Noninvasive cardiac output.; Pediatrics.

Outcome Measures

Primary Outcomes (1)

• Bilateral cardiac output using the Cardiotronic ICON non-invasive cardiac output monitor.

  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.

  6 months

Study Arms (1)

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.

Device: Bilateral cardiac output

Interventions

Bilateral cardiac output DEVICE

Also known as: Cardiotronic ICON non-invasive cardiac output monitor

Bilateral cardiac output

Eligibility Criteria

• Age: 1 Month - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients who will undergo general anesthesia in the operating room from age 1 month old to 8 years old with all types of medical conditions 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.

You may qualify if:

• month old to 8 years old.
• Lower abdominal or lower extremity surgery.

You may not qualify if:

• Less than 1 month old.
• Greater than 8 years old.
• Patients undergoing upper abdominal, thoracic, upper extremity, or head/neck surgery.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• 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.

  PMID: 17039348 BACKGROUND

• 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.

  PMID: 18024954 BACKGROUND

• 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.

  PMID: 17944633 BACKGROUND

Study Officials

• Thomas A Anderson, PhD, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas A Anderson, PhD, MD

CONTACT

617-724-7247; tanderson9@partners.org

Charles J Cote, MD

CONTACT

617-724-2250; cjcote@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Anesthesia

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

US (1)