Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

Sponsor

Instituto Nacional de Cardiologia de Laranjeiras (Other)

Overall Status

Recruiting

CT.gov ID

NCT04766554

Collaborator

(none)

452

Enrollment

Locations

Arms

Anticipated Duration (Months)

226

Patients Per Site

17.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease Cognitive Dysfunction	Device: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

452 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

Actual Study Start Date :

May 19, 2021

Anticipated Primary Completion Date :

Jun 20, 2022

Anticipated Study Completion Date :

Jun 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cerebral Oxymetry Monitoring The following procedures should be performed sequentially in the event of cerebral desaturation after 30 seconds: The positioning of the head, the presence of facial plethora, and bad position of catheters should be corrected; In case of arterial hypotension, the causal factors should be assessed and treated; In the presence of arterial hypoxemia, the causal factors should be assessed and treated to maintain a PaO2 > 150 mmHg; In the presence of hypercapnia, adjust the ventilation parameters avoiding hyperventilation; 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; In cases of SvO2 below 70% and signs of hemodynamic instability, optimize fluid replacement and ventricular global contractility; 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 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.
No Intervention: Control Group 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.

Arm

Intervention/Treatment

Active Comparator: Cerebral Oxymetry Monitoring

The following procedures should be performed sequentially in the event of cerebral desaturation after 30 seconds: The positioning of the head, the presence of facial plethora, and bad position of catheters should be corrected; In case of arterial hypotension, the causal factors should be assessed and treated; In the presence of arterial hypoxemia, the causal factors should be assessed and treated to maintain a PaO2 > 150 mmHg; In the presence of hypercapnia, adjust the ventilation parameters avoiding hyperventilation; 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; In cases of SvO2 below 70% and signs of hemodynamic instability, optimize fluid replacement and ventricular global contractility; 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

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.

No Intervention: Control Group

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.

Outcome Measures

Primary Outcome Measures

Preoperative cognitive function [Pre-surgery (within 10 days before)]
Mini Mental State Examination (MMSE)
Postoperative cognitive dysfunction - delayed cognitive recovery [Post-surgery (7 days after surgery)]
Mini Mental State Examination (MMSE)
Postoperative cognitive dysfunction - neurocognitive disorder [Post-surgery (90 days after surgery)]
Mini Mental State Examination (MMSE)
Preoperative cognitive function II [Pre-surgery (within 10 days before)]
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery II [Post-surgery (7 days after surgery)]
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - neurocognitive disorder II [Post-surgery (90 days after surgery)]
Montreal Cognitive Assessment (MoCA) test
Preoperative cognitive function III [Pre-surgery (within 10 days before)]
The Telephone Interview for Cognitive Status (TICS)
Postoperative cognitive dysfunction - delayed cognitive recovery III [Post-surgery (7 days after surgery)]
The Telephone Interview for Cognitive Status (TICS)
Postoperative cognitive dysfunction - neurocognitive disorder III [Post-surgery (90 days after surgery)]
The Telephone Interview for Cognitive Status (TICS)

Secondary Outcome Measures

Incidence of postoperative delirium [Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge]
Delirium will be assessed postoperatively for seven days or until discharge
Neurological injury type I (stroke) [Post-surgery (until 30 days after surgery)]
The incidence of neurological injury type I will be evaluated for 30 days
Duration of mechanical ventilation [Post-surgery (until 30 days after surgery)]
The duration of mechanical ventilation will be evaluated
Length of stay at the intensive care unit (ICU) [Post-surgery (until 30 days after surgery)]
The length of stay at the intensive care unit (ICU) will be evaluated
Length of stay at the hospital [Post-surgery (until 30 days after surgery)]
The length of stay at the hospital will be evaluated
Incidence of mortality resulting from all causes [Post-surgery (until 30 days after surgery)]
All causes of mortality will be assessed for 30 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Cardiologia	Rio de Janeiro	RJ	Brazil
2	Hospital São José	Criciúma	SC	Brazil

Sponsors and Collaborators

Instituto Nacional de Cardiologia de Laranjeiras

Investigators

Principal Investigator: Carlos Galhardo, MD, Instituto Nacional de Cardiologia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlos Galhardo Jr., Chief of Adult Cardiac Anesthesia Division, Instituto Nacional de Cardiologia de Laranjeiras

ClinicalTrials.gov Identifier:

NCT04766554

Other Study ID Numbers:

COSMICS STUDY

First Posted:

Feb 23, 2021

Last Update Posted:

Aug 27, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carlos Galhardo Jr., Chief of Adult Cardiac Anesthesia Division, Instituto Nacional de Cardiologia de Laranjeiras

Intraoperative Neurophysiologic Monitorings

Additional relevant MeSH terms:

Heart Diseases

Cognitive Dysfunction

Study Results

No Results Posted as of Aug 27, 2021