Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

NCT04766554 | Completed DMC

• 1 other identifier: COSMICS STUDY
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 2

Brief Summary

Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.

Conditions

Cardiac Disease; Cognitive Dysfunction

Keywords

Intraoperative Neurophysiologic Monitorings

Outcome Measures

Primary Outcomes (9)

• Preoperative cognitive function

  Mini Mental State Examination (MMSE)

  Pre-surgery (within 10 days before)

• Postoperative cognitive dysfunction - delayed cognitive recovery

  Mini Mental State Examination (MMSE)

  Post-surgery (7 days after surgery)

• Postoperative cognitive dysfunction - neurocognitive disorder

  Mini Mental State Examination (MMSE)

  Post-surgery (90 days after surgery)

• Preoperative cognitive function II

  Montreal Cognitive Assessment (MoCA) test

  Pre-surgery (within 10 days before)

• Postoperative cognitive dysfunction - delayed cognitive recovery II

  Montreal Cognitive Assessment (MoCA) test

  Post-surgery (7 days after surgery)

• Postoperative cognitive dysfunction - neurocognitive disorder II

  Montreal Cognitive Assessment (MoCA) test

  Post-surgery (90 days after surgery)

• Preoperative cognitive function III

  The Telephone Interview for Cognitive Status (TICS)

  Pre-surgery (within 10 days before)

• Postoperative cognitive dysfunction - delayed cognitive recovery III

  The Telephone Interview for Cognitive Status (TICS)

  Post-surgery (7 days after surgery)

• Postoperative cognitive dysfunction - neurocognitive disorder III

  The Telephone Interview for Cognitive Status (TICS)

  Post-surgery (90 days after surgery)

Secondary Outcomes (6)

• Incidence of postoperative delirium

  Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge

• Neurological injury type I (stroke)

  Post-surgery (until 30 days after surgery)

• Duration of mechanical ventilation

  Post-surgery (until 30 days after surgery)

• Length of stay at the intensive care unit (ICU)

  Post-surgery (until 30 days after surgery)

• Length of stay at the hospital

  Post-surgery (until 30 days after surgery)

Study Arms (2)

Cerebral Oxymetry Monitoring

ACTIVE COMPARATOR

The following procedures should be performed sequentially in the event of cerebral desaturation after 30 seconds: 1. The positioning of the head, the presence of facial plethora, and bad position of catheters should be corrected; 2. In case of arterial hypotension, the causal factors should be assessed and treated; 3. In the presence of arterial hypoxemia, the causal factors should be assessed and treated to maintain a PaO2 \> 150 mmHg; 4. In the presence of hypercapnia, adjust the ventilation parameters avoiding hyperventilation; 5. In the presence of anemia, the causal factors should be assessed, and the decision to undergo transfusion should also take into consideration the presence of tissue hypoperfusion; 6. In cases of SvO2 below 70% and signs of hemodynamic instability, optimize fluid replacement and ventricular global contractility; 7. Assess the increase of brain consumption of O2, avoiding the superficial level of anesthesia, hyperthermia, and tremors.

Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions

Control Group

NO INTERVENTION

Patients will be treated according to the attending anesthesiologist, without the monitoring of cerebral oximetry, but to maintain a heart rate between 70 - 100 bpm, lactate levels \<3 mmol/L and urine output\> 0.5mL/Kg/h. In case of arterial hypotension the causal factors should be assessed and treated; in case of SvO2 below 70% and signs of hemodynamic instability, optimize volume replacement and global ventricular contractility through inotropic agents (epinephrine, dobutamine or milrinone); in the presence of anemia (Hb \<6 to 7g/dL during CPB or Hb \<8g/dL in the pre-CPB or post-CPB period), the causal factors should be assessed and the decision to transfuse should also take into account the presence of hypoperfusion tissue (increased lactate, low SvO2, acidosis); in episodes of bradycardia with hemodynamic instability, atropine may be used.

Interventions

Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions DEVICE

In the intervention group, an alarm threshold below 15% of the baseline rSO2 value will be established. Based on the predetermined algorithm the rSO2 will be maintained at or above 85% of the baseline measurements. If the rSO2 reaches levels below 15% of the baseline values or below 50% in absolute value for over 30 seconds, protocol-based interventions will be performed to restore rSO2 to baseline levels.

Cerebral Oxymetry Monitoring

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 or older
• Elective coronary artery bypass graft surgery using cardiopulmonary bypass
• Preoperative cognitive assessment by means of Mini-Mental State Examination (MMSE) test, greater than or equal to 24
• Signed informed consent

You may not qualify if:

• Patients with focal neurologic deficit
• Carotid artery stenosis greater than 70%
• Patients with pre-existing cognitive dysfunction
• Patients with psychotic disorders
• History of allergy to adhesive part of the electrode
• History of craniofacial surgery

Sponsors & Collaborators

• Instituto Nacional de Cardiologia de Laranjeiras: lead

Study Sites (2)

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital São José

Criciúma, Santa Catarina, Brazil

Location

Related Publications (7)

• Zheng F, Sheinberg R, Yee MS, Ono M, Zheng Y, Hogue CW. Cerebral near-infrared spectroscopy monitoring and neurologic outcomes in adult cardiac surgery patients: a systematic review. Anesth Analg. 2013 Mar;116(3):663-76. doi: 10.1213/ANE.0b013e318277a255. Epub 2012 Dec 24.

  PMID: 23267000 RESULT

• Deschamps A, Hall R, Grocott H, Mazer CD, Choi PT, Turgeon AF, de Medicis E, Bussieres JS, Hudson C, Syed S, Seal D, Herd S, Lambert J, Denault A, Deschamps A, Mutch A, Turgeon A, Denault A, Todd A, Jerath A, Fayad A, Finnegan B, Kent B, Kennedy B, Cuthbertson BH, Kavanagh B, Warriner B, MacAdams C, Lehmann C, Fudorow C, Hudson C, McCartney C, McIsaac D, Dubois D, Campbell D, Mazer D, Neilpovitz D, Rosen D, Cheng D, Drapeau D, Dillane D, Tran D, Mckeen D, Wijeysundera D, Jacobsohn E, Couture E, de Medicis E, Alam F, Abdallah F, Ralley FE, Chung F, Lellouche F, Dobson G, Germain G, Djaiani G, Gilron I, Hare G, Bryson G, Clarke H, McDonald H, Roman-Smith H, Grocott H, Yang H, Douketis J, Paul J, Beaubien J, Bussieres J, Pridham J, Armstrong JN, Parlow J, Murkin J, Gamble J, Duttchen K, Karkouti K, Turner K, Baghirzada L, Szabo L, Lalu M, Wasowicz M, Bautista M, Jacka M, Murphy M, Schmidt M, Verret M, Perrault MA, Beaudet N, Buckley N, Choi P, MacDougall P, Jones P, Drolet P, Beaulieu P, Taneja R, Martin R, Hall R, George R, Chun R, McMullen S, Beattie S, Sampson S, Choi S, Kowalski S, McCluskey S, Syed S, Boet S, Ramsay T, Saha T, Mutter T, Chowdhury T, Uppal V, Mckay W; Canadian Perioperative Anesthesia Clinical Trials Group. Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial. Anesthesiology. 2016 Apr;124(4):826-36. doi: 10.1097/ALN.0000000000001029.

  PMID: 26808629 RESULT

• 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.

  PMID: 19101265 RESULT

• Lei L, Katznelson R, Fedorko L, Carroll J, Poonawala H, Machina M, Styra R, Rao V, Djaiani G. Cerebral oximetry and postoperative delirium after cardiac surgery: a randomised, controlled trial. Anaesthesia. 2017 Dec;72(12):1456-1466. doi: 10.1111/anae.14056. Epub 2017 Sep 22.

  PMID: 28940368 RESULT

• Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015 Mar;47(3):447-54. doi: 10.1093/ejcts/ezu193. Epub 2014 May 7.

  PMID: 24810757 RESULT

• Serraino GF, Murphy GJ. Effects of cerebral near-infrared spectroscopy on the outcome of patients undergoing cardiac surgery: a systematic review of randomised trials. BMJ Open. 2017 Sep 7;7(9):e016613. doi: 10.1136/bmjopen-2017-016613.

  PMID: 28882917 RESULT

• 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. doi: 10.1213/01.ane.0000246814.29362.f4.

  PMID: 17179242 RESULT

MeSH Terms

Conditions

Heart Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carlos Galhardo, MD

  Instituto Nacional de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be masked concerning the allocation group. The anesthesiologist responsible for conducting the case will not be involved in the application of the neurocognitive tests, nor will he be aware of the test results. Investigators who apply the tests will be covered up by the patient allocation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adult Cardiac Anesthesia Division

Model Details: Patients will be monitored with cerebral oximetry using INVOS 5100 monitor (Covidien, Boulder, CO), with electrodes applied bilaterally in the frontal region. Following the placement of the electrodes, the baseline records HR, blood pressure, rSO2, and peripheral O2 saturation (SPO2) will be recorded following 1 minute of electrode placement and the proper verification of the signal on the monitor. Later, during the surgery, if the rSO2 reaches levels below 15% of the baseline values or below 50% in absolute value for over 30 seconds, protocol-based interventions will be performed in the intervention group to return the oximeter to baseline values. The alarm on the equipment should be programmed to signal values below 15% of the baseline values.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 23, 2021
• Study Start: May 19, 2021
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)