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

Status unconfirmed

Conditions studied: Anesthesiology, Pediatrics, General Surgery, Orthopedics, General Anesthesia, Cardiac Output

In brief

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.

Key facts

Study ID

NCT01678066

Run by

Massachusetts General Hospital

People needed

50

Starts

2012-09-01

Expected to finish

2013-02-01

Last updated by the study team

2012-09-03

Who can join

Age: 0 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.