Cerebral Hypoxia Clinical Trial
— Tête-à-coeurOfficial title:
Perioperative Interventions to Optimize Cerebral Oxygen Saturation (rSO2) in High-risk Patients Undergoing Cardiac Surgery Should Have a Beneficial Systemic Effect for Enhancing Global Tissue Perfusion and Improve Outcomes.
Verified date | October 2015 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Using the brain and the heart as index organs, perioperative interventions to optimize cerebral oxygen saturation and cardiac contractility in high-risk patients undergoing cardiac surgery should have a beneficial systemic effect for enhancing global tissue perfusion and improve outcomes.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 2013 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with EUROSCORES = 10. - Planned complex surgery including more than one procedure, or redo procedures. - Patient able to read and understand the consent form. - Patients = 18 years of age. Exclusion Criteria: - High risk patients undergoing of off pump coronary artery bypass. - Emergency surgeries less than 6 hours from diagnosis. - Patient unable to read and understand the consent form. - Patients with and IABP or a ventricular assist device - Planned circulatory arrest - Planned surgery of the descending aorta. - Patients with acute endocarditis. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute | Université de Montréal |
Canada,
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
de Tournay-Jetté E, Denault A, Dupuis G, Cartier R, Deschamps A, Bherer L: Cerebral oxygen saturation (rSO2) changes and post cognitive decline in elderly patients undergoing coronary artery bypass surgery. en préparation
Denault A, Deschamps A, Murkin JM. A proposed algorithm for the intraoperative use of cerebral near-infrared spectroscopy. Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):274-81. doi: 10.1177/1089253207311685. — View Citation
Deschamps A, Rochon A, Lebon J-S, Ayoub C, Qizilbash B, Couture P, Cogan J, Toledano K, Bélisle S, Hemmings G, Taillefer J, Blain R, Denault A: Decreases in Cerebal Oxygen Saturation: an algorithmic approach. Canadian Anaesthetists' Society Journal 2009; Abstract: #613224
Edmonds HL Jr, Ganzel BL, Austin EH 3rd. Cerebral oximetry for cardiac and vascular surgery. Semin Cardiothorac Vasc Anesth. 2004 Jun;8(2):147-66. Review. — View Citation
Fergusson DA, Hébert PC, Mazer CD, Fremes S, MacAdams C, Murkin JM, Teoh K, Duke PC, Arellano R, Blajchman MA, Bussières JS, Côté D, Karski J, Martineau R, Robblee JA, Rodger M, Wells G, Clinch J, Pretorius R; BART Investigators. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med. 2008 May 29;358(22):2319-31. doi: 10.1056/NEJMoa0802395. Epub 2008 May 14. Erratum in: N Engl J Med. 2010 Sep 23;363(13):1290. — View Citation
Gracias VH, Guillamondegui OD, Stiefel MF, Wilensky EM, Bloom S, Gupta R, Pryor JP, Reilly PM, Leroux PD, Schwab CW. Cerebral cortical oxygenation: a pilot study. J Trauma. 2004 Mar;56(3):469-72; discussion 472-4. — View Citation
Hadolt I, Litscher G. Noninvasive assessment of cerebral oxygenation during high altitude trekking in the Nepal Himalayas (2850-5600 m). Neurol Res. 2003 Mar;25(2):183-8. — View Citation
Jöbsis FF. Non-invasive, infra-red monitoring of cerebral O2 sufficiency, bloodvolume, HbO2-Hb shifts and bloodflow. Acta Neurol Scand Suppl. 1977;64:452-3. — View Citation
Kurth CD, Steven JL, Montenegro LM, Watzman HM, Gaynor JW, Spray TL, Nicolson SC. Cerebral oxygen saturation before congenital heart surgery. Ann Thorac Surg. 2001 Jul;72(1):187-92. — View Citation
Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. — View Citation
Shojima M, Watanabe E, Mayanagi Y. Cerebral blood oxygenation after cerebrospinal fluid removal in hydrocephalus measured by near infrared spectroscopy. Surg Neurol. 2004 Oct;62(4):312-8; discussion 318. — View Citation
Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070. — View Citation
Sokol DK, Markand ON, Daly EC, Luerssen TG, Malkoff MD. Near infrared spectroscopy (NIRS) distinguishes seizure types. Seizure. 2000 Jul;9(5):323-7. — View Citation
Taillefer MC, Denault AY. Cerebral near-infrared spectroscopy in adult heart surgery: systematic review of its clinical efficacy. Can J Anaesth. 2005 Jan;52(1):79-87. Review. — View Citation
Vernieri F, Tibuzzi F, Pasqualetti P, Rosato N, Passarelli F, Rossini PM, Silvestrini M. Transcranial Doppler and near-infrared spectroscopy can evaluate the hemodynamic effect of carotid artery occlusion. Stroke. 2004 Jan;35(1):64-70. Epub 2003 Dec 18. — View Citation
Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success rate of reversing decreases in cerebral oxygen saturation below 10% of baseline values to values within 10% of baseline in the INTERVENTION group. | Consensus on the appropriate strategies to prevent and reverse cerebral oxygen desaturations remains controversial. In a recent study by Slater and al.12, randomization into an intervention group failed because anesthesiologists were unable to follow the protocol aimed at strategies to reverse decreases in rSO2. A group from the Montreal Heart Institute has developed a physiologically oriented algorithm to help with the task of reversing decreases in rSO2. The goal of the present study is therefore to confirm that this approach can be used with success by most institutions. | Up to 12 hours | No |
Secondary | First 30 days post-operative outcomes | readmission to hospital within 30 days death |
30 days | No |
Secondary | ICU data | ICU admission and discharge times tracheal extubation time in hours |
Up to 48 hours | No |
Secondary | First 24 hours complications | clinical stroke manifested as focal neurological deficit persisting 24hr and confirmed by brain computed tomography imaging prolonged ventilation defined as extubation at > 24 h postoperatively new, persistent Q-wave myocardial infarction |
24 hours | No |
Secondary | Post-operative complications | renal failure as defined by the RIFLE criteria reoperation for any cause arrhythmia requiring treatment Hospital length of stay wound infection requiring specific antibiotic coverage |
Up to 7 days | No |
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