Cardiac DiseaseCOSMICSNCT04766554
Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
A study testing Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions in people with Cardiac Disease and Cognitive Dysfunction, run by Instituto Nacional de Cardiologia de Laranjeiras at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Disease, Cognitive Dysfunction
- What is being tested?
- Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 2 sitesBrazil
- Study dates
- 19 May 2021to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital São José
Criciúma, Santa Catarina
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
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.
Read the detailed description
Despite all the progress over the last decades regarding the improvement of the perioperative care of patients with heart disease and the development of new surgical techniques, neurological dysfunction continues to be one of the complications of the greatest concern in patients undergoing cardiac surgery with cardiopulmonary bypass. Brain injury can manifest itself through permanent or temporary injury, contributing to the increase in-hospital mortality, in the length of stay in intensive care, in the length of hospital stay, to a higher incidence of motor dysfunction requiring rehabilitation, and consequently, to reduced quality of life.
Even though the causes of brain injury are multifactorial, perioperative cerebral hypoperfusion, tissue hypoxia, and thromboembolic events are among the main factors related to neurological dysfunction.
Several clinical studies have indicated an association between cerebral desaturation and the increase of neurological complications. Cerebral oximetry monitoring using near-infrared spectroscopy (NIRS) is a non-invasive technique used to estimate regional cerebral oxygen saturation (rSO2) and has been associated with diminishing the incidence of neurological complications.
There is no consensus in the literature about its real benefit, mainly due to the absence of well-designed scientific studies that demonstrate that cerebral desaturation associated with intervention measures to improve rSO2, are related to the prevention of neurological dysfunction in adult cardiac surgery.
The study hypothesis evaluates whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with early interventions to optimize rSO2.
- Conditions
- Cardiac Disease, Cognitive Dysfunction
- Being tested
- Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions
- Keywords
- Intraoperative Neurophysiologic Monitorings
- Medical subject headings
- Heart Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventionsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative cognitive function
Mini Mental State Examination (MMSE)
Measured: Pre-surgery (within 10 days before)
Postoperative cognitive dysfunction - delayed cognitive recovery
Mini Mental State Examination (MMSE)
Measured: Post-surgery (7 days after surgery)
Postoperative cognitive dysfunction - neurocognitive disorder
Mini Mental State Examination (MMSE)
Measured: Post-surgery (90 days after surgery)
Preoperative cognitive function II
Montreal Cognitive Assessment (MoCA) test
Measured: Pre-surgery (within 10 days before)
Postoperative cognitive dysfunction - delayed cognitive recovery II
Montreal Cognitive Assessment (MoCA) test
Measured: Post-surgery (7 days after surgery)
Postoperative cognitive dysfunction - neurocognitive disorder II
Montreal Cognitive Assessment (MoCA) test
Measured: Post-surgery (90 days after surgery)
Preoperative cognitive function III
The Telephone Interview for Cognitive Status (TICS)
Measured: Pre-surgery (within 10 days before)
Postoperative cognitive dysfunction - delayed cognitive recovery III
The Telephone Interview for Cognitive Status (TICS)
Measured: Post-surgery (7 days after surgery)
Postoperative cognitive dysfunction - neurocognitive disorder III
The Telephone Interview for Cognitive Status (TICS)
Measured: Post-surgery (90 days after surgery)
Secondary outcomes (6)
Incidence of postoperative delirium
Delirium will be assessed postoperatively for seven days or until discharge
Measured: Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge
Neurological injury type I (stroke)
The incidence of neurological injury type I will be evaluated for 30 days
Measured: Post-surgery (until 30 days after surgery)
Duration of mechanical ventilation
The duration of mechanical ventilation will be evaluated
Measured: Post-surgery (until 30 days after surgery)
Length of stay at the intensive care unit (ICU)
The length of stay at the intensive care unit (ICU) will be evaluated
Measured: Post-surgery (until 30 days after surgery)
Length of stay at the hospital
The length of stay at the hospital will be evaluated
Measured: Post-surgery (until 30 days after surgery)
Incidence of mortality resulting from all causes
All causes of mortality will be assessed for 30 days
Measured: Post-surgery (until 30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start19 May 2021
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia de Laranjeiras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Galhardo Jr., Instituto Nacional de Cardiologia de Laranjeiras
- Investigators
- Carlos Galhardo, MD, Principal investigator, Instituto Nacional de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766554
- Sponsor's protocol ID
- COSMICS STUDY
- Acronym
- COSMICS
- Status last verified
- Jan 2026
- First submitted
- 16 Feb 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23267000Deschamps 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.
PubMed 26808629Slater 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.
PubMed 19101265Lei 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.
PubMed 28940368Colak 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.
PubMed 24810757Serraino 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.
PubMed 28882917Murkin 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.
PubMed 17179242
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
- ClinicalTrials.gov ID
- NCT04766554
- Acronym / sponsor ID
- COSMICS / COSMICS STUDY
- Conditions
- Cardiac Disease, Cognitive Dysfunction
- Keywords
- Intraoperative Neurophysiologic Monitorings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Instituto Nacional de Cardiologia de LaranjeirasUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite all the progress over the last decades regarding the improvement of the perioperative care of patients with heart disease and the development of new surgical techniques, neurological dysfunction continues to be one of the complications of the greatest concern in patients undergoing cardiac surgery with cardiopulmonary bypass. Brain injury can manifest itself through permanent or temporary injury, contributing to the increase in-hospital mortality, in the length of stay in intensive care, in the length of hospital stay, to a higher incidence of motor dysfunction requiring rehabilitation, and consequently, to reduced quality of life.
Even though the causes of brain injury are multifactorial, perioperative cerebral hypoperfusion, tissue hypoxia, and thromboembolic events are among the main factors related to neurological dysfunction.
Several clinical studies have indicated an association between cerebral desaturation and the increase of neurological complications. Cerebral oximetry monitoring using near-infrared spectroscopy (NIRS) is a non-invasive technique used to estimate regional cerebral oxygen saturation (rSO2) and has been associated with diminishing the incidence of neurological complications.
There is no consensus in the literature about its real benefit, mainly due to the absence of well-designed scientific studies that demonstrate that cerebral desaturation associated with intervention measures to improve rSO2, are related to the prevention of neurological dysfunction in adult cardiac surgery.
The study hypothesis evaluates whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with early interventions to optimize rSO2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cerebral Oxymetry Monitoring | Active comparator | Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventionsThe 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventionsIn 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. | Device | Cerebral Oxymetry Monitoring |
Primary outcome
Preoperative cognitive function
Time frame: Pre-surgery (within 10 days before)
Mini Mental State Examination (MMSE)
Postoperative cognitive dysfunction - delayed cognitive recovery
Time frame: Post-surgery (7 days after surgery)
Mini Mental State Examination (MMSE)
Postoperative cognitive dysfunction - neurocognitive disorder
Time frame: Post-surgery (90 days after surgery)
Mini Mental State Examination (MMSE)
Preoperative cognitive function II
Time frame: Pre-surgery (within 10 days before)
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery II
Time frame: Post-surgery (7 days after surgery)
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - neurocognitive disorder II
Time frame: Post-surgery (90 days after surgery)
Montreal Cognitive Assessment (MoCA) test
Preoperative cognitive function III
Time frame: Pre-surgery (within 10 days before)
The Telephone Interview for Cognitive Status (TICS)
Postoperative cognitive dysfunction - delayed cognitive recovery III
Time frame: Post-surgery (7 days after surgery)
The Telephone Interview for Cognitive Status (TICS)
Postoperative cognitive dysfunction - neurocognitive disorder III
Time frame: Post-surgery (90 days after surgery)
The Telephone Interview for Cognitive Status (TICS)
6 secondary outcomes
Incidence of postoperative delirium
Time frame: Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge
Neurological injury type I (stroke)
Time frame: Post-surgery (until 30 days after surgery)
Duration of mechanical ventilation
Time frame: Post-surgery (until 30 days after surgery)
Length of stay at the intensive care unit (ICU)
Time frame: Post-surgery (until 30 days after surgery)
Length of stay at the hospital
Time frame: Post-surgery (until 30 days after surgery)
Incidence of mortality resulting from all causes
Time frame: Post-surgery (until 30 days after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Results publication: PubMed 23267000Zheng 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.
- Results publication: PubMed 26808629Deschamps 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.
- Results publication: PubMed 19101265Slater 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.
- Results publication: PubMed 28940368Lei 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.
- Results publication: PubMed 24810757Colak 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.
- Results publication: PubMed 28882917Serraino 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.
- Results publication: PubMed 17179242Murkin 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.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Galhardo, MD principal investigator
Instituto Nacional de Cardiologia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions in people with Cardiac Disease and Cognitive Dysfunction, run by Instituto Nacional de Cardiologia de Laranjeiras at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative cognitive function (time frame: Pre-surgery (within 10 days before)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766554, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.