NCT05267782 - 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)

Domenick Sridharan N, Thirumala P, Chaer R, Balzer J, Long B, Crammond D, Makaroun M, Avgerinos E
Predictors of cross-clamp-induced intraoperative monitoring changes during carotid endarterectomy using both electroencephalography and somatosensory evoked potentials. J Vasc Surg. 2018 Jan;67(1):191-198. doi: 10.1016/j.jvs.2017.04.064. Epub 2017 Jul 5.
Friedell ML, Clark JM, Graham DA, Isley MR, Zhang XF
Cerebral oximetry does not correlate with electroencephalography and somatosensory evoked potentials in determining the need for shunting during carotid endarterectomy. J Vasc Surg. 2008 Sep;48(3):601-6. doi: 10.1016/j.jvs.2008.04.065. Epub 2008 Jul 18.
https://www
masimo.com/siteassets/us/documents/pdf/plm_11661c_brochure_o3_series_us.pdf
https://www
masimo.com/technology/brain-monitoring/cerebral-oximetry
Nwachuku EL, Balzer JR, Yabes JG, Habeych ME, Crammond DJ, Thirumala PD
Diagnostic value of somatosensory evoked potential changes during carotid endarterectomy: a systematic review and meta-analysis. JAMA Neurol. 2015 Jan;72(1):73-80. doi: 10.1001/jamaneurol.2014.3071.
Tan TW, Garcia-Toca M, Marcaccio EJ Jr, Carney WI Jr, Machan JT, Slaiby JM
Predictors of shunt during carotid endarterectomy with routine electroencephalography monitoring. J Vasc Surg. 2009 Jun;49(6):1374-8. doi: 10.1016/j.jvs.2009.02.206.

Correlation Between New O3 Regional Oximetry, Electroencephalography and the Somatosensory Evoked Potential in Carotid Endarterectomy Surgery

Clinical trial NCT05267782 - References