NCT05508711 - 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)

Maeda T, Hamaguchi E, Kubo N, Shimokawa A, Kanazawa H, Ohnishi Y
The accuracy and trending ability of cardiac index measured by the fourth-generation FloTrac/Vigileo system™ and the Fick method in cardiac surgery patients. J Clin Monit Comput. 2019 Oct;33(5):767-776. doi: 10.1007/s10877-018-0217-1. Epub 2018 Nov 7.
Mayer J, Boldt J, Wolf MW, Lang J, Suttner S
Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008 Mar;106(3):867-72, table of contents. doi: 10.1213/ane.0b013e318161964d. Retraction in: Anesth Analg. 2011 May;112(5):1074.
McLean AS, Huang SJ, Kot M, Rajamani A, Hoyling L
Comparison of cardiac output measurements in critically ill patients: FloTrac/Vigileo vs transthoracic Doppler echocardiography. Anaesth Intensive Care. 2011 Jul;39(4):590-8.
Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group
Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major
Suehiro K, Tanaka K, Mikawa M, Uchihara Y, Matsuyama T, Matsuura T, Funao T, Yamada T, Mori T, Nishikawa K
Improved Performance of the Fourth-Generation FloTrac/Vigileo System for Tracking Cardiac Output Changes. J Cardiothorac Vasc Anesth. 2015;29(3):656-62. doi: 10.1053/j.jvca.2014.07.022. Epub 2014 Nov 14.
Vender JS
Clinical utilization of pulmonary artery catheter monitoring. Int Anesthesiol Clin. 1993 Summer;31(3):57-85. Review.

Comparability of Transesophageal Echocardiography and Continuous Mini-invasive FloTrac/Vigileo System (© Edwards Lifesciences) for the Determination of Cardiac Output in Three Different Positions During General Anesthesia

Details for clinical trial NCT05508711

Clinical trial NCT05508711 - References