Myocardial Infarction Clinical Trial
Official title:
Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery
NCT number | NCT01838733 |
Other study ID # | B2013:015 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | April 20, 2013 |
Last updated | November 11, 2016 |
Start date | April 2014 |
Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The
definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the
association between desaturations and perioperative outcome, and the mechanistic
explanations of cerebral desaturations remain unexamined. This study seeks to identify the
true incidence and magnitude of cerebral desaturations in high-risk non-cardiac surgical
patients and the association between desaturations and perioperative outcome.
The investigators will attempt to determine the following (1) The proper definition,
incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac
surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with
alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin
concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of
decreased rSO2 with relevant perioperative.
The investigators will also analyze a panel of inflammatory biomarkers to determine if these
biomarkers have the ability to predict postoperative complications.
The investigators will study 200 high-risk patients undergoing high-risk non-cardiac
surgery. The investigators will determine the incidence and severity of decreases in rSO2,
the associated factors with the occurrence of decreased rSO2, and the relationship between
decreases in rSO2 and adverse perioperative outcome with a composite of well defined
perioperative complications such as death, myocardial infarction, cerebrovascular accident,
acute kidney injury, delirium, postoperative infections, and the need for mechanical
ventilation.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age >65 - High risk surgery (aortic aneurysm repair, hepatic resection, pancreatectomy, colon resection) Exclusion Criteria: - Previous stroke - Dementia |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Center | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Canadian Anesthesia Research Foundation |
Canada,
Apostolidou I, Morrissette G, Sarwar MF, Konia MR, Kshettry VR, Wahr JA, Lobbestael AA, Nussmeier NA. Cerebral oximetry during cardiac surgery: the association between cerebral oxygen saturation and perioperative patient variables. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1015-21. doi: 10.1053/j.jvca.2012.07.011. — View Citation
Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup.. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. Review. — View Citation
Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Danelli G, Fierro G, De Cosmo G, Servillo G. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005 Sep;101(3):740-7, table of contents. Erratum in: Anesth Analg. 2006 Jun;102(6):1645. Fierro, Giovanni [corrected to Fierro, Giuseppe]. — View Citation
Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Montanini S; Collaborative Italian Study Group on Anaesthesia in Elderly Patients., Danelli G, Nuzzi M, Mentegazzi F, Torri G, Martani C, Spreafico E, Fierro G, Pugliese F, De Cosmo G, Aceto P, Servillo G, Monaco F. Monitoring cerebral oxygen saturation in elderly patients undergoing general abdominal surgery: a prospective cohort study. Eur J Anaesthesiol. 2007 Jan;24(1):59-65. — View Citation
Casati A, Spreafico E, Putzu M, Fanelli G. New technology for noninvasive brain monitoring: continuous cerebral oximetry. Minerva Anestesiol. 2006 Jul-Aug;72(7-8):605-25. Review. English, Italian. — View Citation
Colak Z, Borojevic M, Ivancan V, Gabelica R, Biocina B, Majeric-Kogler V. The relationship between prolonged cerebral oxygen desaturation and postoperative outcome in patients undergoing coronary artery bypass grafting. Coll Antropol. 2012 Jun;36(2):381-8. — View Citation
Davie SN, Grocott HP. Impact of extracranial contamination on regional cerebral oxygen saturation: a comparison of three cerebral oximetry technologies. Anesthesiology. 2012 Apr;116(4):834-40. doi: 10.1097/ALN.0b013e31824c00d7. — View Citation
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. — View Citation
Green DW. A retrospective study of changes in cerebral oxygenation using a cerebral oximeter in older patients undergoing prolonged major abdominal surgery. Eur J Anaesthesiol. 2007 Mar;24(3):230-4. — View Citation
Hoppenstein D, Zohar E, Ramaty E, Shabat S, Fredman B. The effects of general vs spinal anesthesia on frontal cerebral oxygen saturation in geriatric patients undergoing emergency surgical fixation of the neck of femur. J Clin Anesth. 2005 Sep;17(6):431-8. — View Citation
Kwak HJ, Park SK, Lee KC, Lee DC, Kim JY. High positive end-expiratory pressure preserves cerebral oxygen saturation during laparoscopic cholecystectomy under propofol anesthesia. Surg Endosc. 2013 Feb;27(2):415-20. doi: 10.1007/s00464-012-2447-5. — View Citation
Lee A, Kim SH, Hong JY, Hwang JH. Effect of anesthetic methods on cerebral oxygen saturation in elderly surgical patients: prospective, randomized, observational study. World J Surg. 2012 Oct;36(10):2328-34. doi: 10.1007/s00268-012-1676-z. — View Citation
Meng L, Cannesson M, Alexander BS, Yu Z, Kain ZN, Cerussi AE, Tromberg BJ, Mantulin WW. Effect of phenylephrine and ephedrine bolus treatment on cerebral oxygenation in anaesthetized patients. Br J Anaesth. 2011 Aug;107(2):209-17. doi: 10.1093/bja/aer150. — View Citation
Morimoto Y, Yoshimura M, Utada K, Setoyama K, Matsumoto M, Sakabe T. Prediction of postoperative delirium after abdominal surgery in the elderly. J Anesth. 2009;23(1):51-6. doi: 10.1007/s00540-008-0688-1. — View Citation
Paarmann H, Heringlake M, Heinze H, Hanke T, Sier H, Karsten J, Schön J. Non-invasive cerebral oxygenation reflects mixed venous oxygen saturation during the varying haemodynamic conditions in patients undergoing transapical transcatheter aortic valve implantation. Interact Cardiovasc Thorac Surg. 2012 Mar;14(3):268-72. doi: 10.1093/icvts/ivr102. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cerebral desaturation | Intraoperative | No | |
Secondary | Composite outcome of adverse peri-operative outcome | Death, myocardial infarction, cerebrovascular accident, acute kidney injury (defined by the AKIN criteria), delirium (as defined by the CAM-ICU method), postoperative infections, and the need for mechanical ventilation >24 hours in the first 28 postoperative days. | 28 days | No |
Secondary | Levels of perioperative inflammatory biomarkers | Levels of a panel of inflammatory biomarkers | 24 Hours | No |
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