Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery - Full Text View

Purpose

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.

Condition	Intervention
Cerebral Hypoxia	Procedure: strategies to reverse decrease in rSO2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official 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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:

Perioperative complications [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
-new, persistent Q-wave myocardial infarction

Secondary Outcome Measures:

First 30 days post-operative outcomes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- readmission to hospital within 30 days
- death
ICU data [ Time Frame: Up to 48 hours ] [ Designated as safety issue: No ]
- ICU admission and discharge times
- tracheal extubation time in hours
First 24 hours complications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- 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
Post-operative complications [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
- 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

Estimated Enrollment:	200
Study Start Date:	July 2010
Estimated Study Completion Date:	September 2013
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intervention an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.	Procedure: strategies to reverse decrease in rSO2 an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values. Other Name: Cerebral Oxymetry decrease
No Intervention: Control the cerebral oxymetry screen will be blinded and changes in NIRS values will be unknown to the anesthesiologist. The management of the case will proceed as per normal local practice. The screen will remain blinded in the ICU and the intensivist will not see the values.

Arms

Assigned Interventions

Active Comparator: Intervention

an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.

Procedure: strategies to reverse decrease in rSO2

an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.

Other Name: Cerebral Oxymetry decrease

No Intervention: Control

the cerebral oxymetry screen will be blinded and changes in NIRS values will be unknown to the anesthesiologist. The management of the case will proceed as per normal local practice. The screen will remain blinded in the ICU and the intensivist will not see the values.

Detailed Description:

The proportion of high-risk patients requiring cardiac surgery and of high-risk cardiac surgeries is increasing. These populations of patients are at increased risk of perioperative morbidity and mortality. Transesophageal echocardiography (TEE) evaluation in cardiac surgery has been shown to impact on the perioperative management of patients and to improve outcomes. Near infrared-reflectance spectroscopy (NIRS) is a technique that has been employed since the mid-1970's and that can be used as a non-invasive and continuous monitor of the balance between cerebral oxygen delivery and consumption. Two recent randomized trials have shown an association between correction of cerebral desaturation and shorter recovery room and hospital stay in non-cardiac surgery, and with a decrease in major organ dysfunction and in intensive care length of stay after coronary artery bypass. By combining NIRS and TEE in high-risk patients, optimal tissue perfusion could be achieved and perioperative morbidity and mortality could be reduced.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432184

Contacts

Contact: Jonathan Lacharite, RRT	514-376-3330 ext 3725	jonathan.lacharite@icm-mhi.org
Contact: Alain Deschamps, MD, FRCPC	514-376-3330 ext 3732	a.deschamps@umontreal.ca

Locations

Canada, Quebec
Montreal Heart Institute	Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Jonathan Lacharite, RRT 514-376-3330 ext 3725 jonathan.lacharite@icm-mhi.org
Contact: Micheline Roy, RRT, CCRP 514-376-3330 ext 3725 micheline.roy@icm-mhi.org
Principal Investigator: Alain Deschamps, MD, FRCPC

Sponsors and Collaborators

Montreal Heart Institute

Université de Montréal

Investigators

Principal Investigator:

Alain Deschamps, MD, FRCPC

Montreal Heart Institute

More Information

Publications:

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.

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.

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.

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].

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.

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.

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. No abstract available.

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.

Sokol DK, Markand ON, Daly EC, Luerssen TG, Malkoff MD. Near infrared spectroscopy (NIRS) distinguishes seizure types. Seizure. 2000 Jul;9(5):323-7.

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.

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.

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.

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.

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. Epub 2008 May 14. Erratum in: N Engl J Med. 2010 Sep 23;363(13):1290.

Responsible Party:	Alain Deschamps, PhD, MD, FRCPC,, Montreal Heart Institute
ClinicalTrials.gov Identifier:	NCT01432184 History of Changes
Other Study ID Numbers:	ICM 08-1009
Study First Received:	August 26, 2011
Last Updated:	April 23, 2013
Health Authority:	Canada: Health Canada

Keywords provided by Montreal Heart Institute:

cerebral
hypoxia

Additional relevant MeSH terms:

Anoxia
Hypoxia, Brain
Signs and Symptoms, Respiratory
Signs and Symptoms

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013

Feasibility Trial to Maintain Normal Cerebral Oxygen Saturation in High-Risk Cardiac Surgery (Tête-à-coeur)