Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

Cardiac Disease Clinical Trial

— COSMICS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766554
• Other study ID #: COSMICS STUDY
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: July 20, 2024

Study information

• Verified date: May 2024
• Source: Instituto Nacional de Cardiologia de Laranjeiras
• Contact: Carlos Galhardo, MD
• Phone: +55(21)999115844
• Email: cgalhardo[@]uol.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cognitive Dysfunction
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital São José	Criciúma	SC
Brazil	Instituto Nacional de Cardiologia	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia de Laranjeiras

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. 20 — View Citation

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, Cuthbe — View Citation

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.140 — 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. doi: 10.1213 — View Citation

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. — 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 Ja — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative cognitive function	Mini Mental State Examination (MMSE)	Pre-surgery (within 10 days before)
Primary	Postoperative cognitive dysfunction - delayed cognitive recovery	Mini Mental State Examination (MMSE)	Post-surgery (7 days after surgery)
Primary	Postoperative cognitive dysfunction - neurocognitive disorder	Mini Mental State Examination (MMSE)	Post-surgery (90 days after surgery)
Primary	Preoperative cognitive function II	Montreal Cognitive Assessment (MoCA) test	Pre-surgery (within 10 days before)
Primary	Postoperative cognitive dysfunction - delayed cognitive recovery II	Montreal Cognitive Assessment (MoCA) test	Post-surgery (7 days after surgery)
Primary	Postoperative cognitive dysfunction - neurocognitive disorder II	Montreal Cognitive Assessment (MoCA) test	Post-surgery (90 days after surgery)
Primary	Preoperative cognitive function III	The Telephone Interview for Cognitive Status (TICS)	Pre-surgery (within 10 days before)
Primary	Postoperative cognitive dysfunction - delayed cognitive recovery III	The Telephone Interview for Cognitive Status (TICS)	Post-surgery (7 days after surgery)
Primary	Postoperative cognitive dysfunction - neurocognitive disorder III	The Telephone Interview for Cognitive Status (TICS)	Post-surgery (90 days after surgery)
Secondary	Incidence of postoperative delirium	Delirium will be assessed postoperatively for seven days or until discharge	Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge
Secondary	Neurological injury type I (stroke)	The incidence of neurological injury type I will be evaluated for 30 days	Post-surgery (until 30 days after surgery)
Secondary	Duration of mechanical ventilation	The duration of mechanical ventilation will be evaluated	Post-surgery (until 30 days after surgery)
Secondary	Length of stay at the intensive care unit (ICU)	The length of stay at the intensive care unit (ICU) will be evaluated	Post-surgery (until 30 days after surgery)
Secondary	Length of stay at the hospital	The length of stay at the hospital will be evaluated	Post-surgery (until 30 days after surgery)
Secondary	Incidence of mortality resulting from all causes	All causes of mortality will be assessed for 30 days	Post-surgery (until 30 days after surgery)