NCT02991976|Completed
Oxygen Concentration and Recovery After Carotid Endarterectomy
Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
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Effects of High Inspiratory Oxygen on Cerebral Tissue Oxygenation and Patient Recovery After Carotid Endarterectomy
Sponsor study identifier
interventional
80
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 5, 2016
Actual (reported)December 14, 2016
Actual (reported)August 2017
Actual (reported)August 2017
Actual (reported)Area under curve of regional cerebral oxygen saturation (rSO2) curve
Intraoperative high oxygen concentrations may reduce intensity of tissue hypoxic episodes during carotid endarterectomy in total intravenous anesthesia (TIVA). The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for Area under curve (AUC) calculations. Data were analyzed using two sided T-test and Fisher exact test. A P\<0.05 was considered as statistically significant Postoperative follow up in large patient's group is necessary to confirm its impact on patients' outcome.
During surgery
Early neurologic recovery, TIA or brain ischemia
Till 7 days after surgery
Patient receiving 35% O2 during carotid endarterectomy, Intervention - oxygen concentration
Patient receiving 100% O2 during carotid endarterectomy, Intervention - oxygen concentration
Shunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Osijek Hospital University
Osijek, County of Osijek-Baranja, 31000, Croatia
Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.
Picton P, Chambers J, Shanks A, Dorje P. The influence of inspired oxygen fraction and end-tidal carbon dioxide on post-cross-clamp cerebral oxygenation during carotid endarterectomy under general anesthesia. Anesth Analg. 2010 Feb 1;110(2):581-7. doi: 10.1213/ANE.0b013e3181c5f160. Epub 2009 Dec 2.
slavica kvolik, prof.
Osijek Hospital University
80 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2016
First Posted
December 14, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Intensive Care Unit admission, Death
Till 7 days after surgery
Contact the study team to confirm eligibility.
Nielsen HB. Systematic review of near-infrared spectroscopy determined cerebral oxygenation during non-cardiac surgery. Front Physiol. 2014 Mar 17;5:93. doi: 10.3389/fphys.2014.00093. eCollection 2014.
Rokamp KZ, Secher NH, Eiberg J, Lonn L, Nielsen HB. O2 supplementation to secure the near-infrared spectroscopy determined brain and muscle oxygenation in vascular surgical patients: a presentation of 100 cases. Front Physiol. 2014 Feb 25;5:66. doi: 10.3389/fphys.2014.00066. eCollection 2014.
Hojlund J, Sandmand M, Sonne M, Mantoni T, Jorgensen HL, Belhage B, van Lieshout JJ, Pott FC. Effect of head rotation on cerebral blood velocity in the prone position. Anesthesiol Res Pract. 2012;2012:647258. doi: 10.1155/2012/647258. Epub 2012 Sep 5.
Wolff CB. Oxygen delivery: the principal role of the circulation. Adv Exp Med Biol. 2013;789:37-42. doi: 10.1007/978-1-4614-7411-1_6.
Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)Last Updated
September 25, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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