NCT01678066 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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. Epub 2007 Nov 16.
Suttner S, Schöllhorn T, Boldt J, Mayer J, Röhm 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. Epub 2006 Oct 13. Retraction in: Intensive Care Med. 2011 Jul;37(7):1232.
Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schälte G
Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9.

A Prospective Study to Bilaterally Compare a New FDA-Approved Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia

Clinical trial NCT01678066 - References