A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia

Completed

Conditions studied: Children Receiving General Anesthesia

In brief

Traditionally cardiac output has been estimated with thermodilution. Recently a new non-invasive device has been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous physiologic data for all enrolled children by transferring the data from the investigators computerized anesthesia records to Excel spreadsheets and to correlate adverse events across monitoring devices. Secondary outcomes: To determine if the device provides meaningful data in terms of an early warning of decreased cardiac output in specific subgroups of children undergoing surgery and anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those undergoing procedures with expected blood loss, those undergoing laparoscopic procedures where gas insufflation may impede venous return to the heart.

Key facts

Study ID

NCT01499615

Run by

Massachusetts General Hospital

People needed

402

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2015-04-09

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All children presenting to our operating rooms for general anesthesia

You may not qualify if…

• Cardiac surgery, open chest procedures

Where it is running

• Operating rooms and GI endoscopy suites of the Massachusetts GeneralHospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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