Peri-operative Monitoring of Cerebral Oxygenation and the Onset of Delirium in Patients Undergoing Cardiac Surgery

NCT ID: NCT02532530

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-03-01

Brief Summary

Delirium is an acute brain syndrome characterized by a disturbance in consciousness accompanied by periods of inattention and changes in cognition. Memory impairment, irrelevant speech and disorientation are commonly observed signs and symptoms. Episodes of delirium have been associated with a prolonged hospital stay, functional and cognitive dysfunction and even an increased mortality. Delirium is a common complication in the postoperative setting where the incidence increases with the risk of surgery. The estimated incidence of postoperative delirium after cardiovascular surgery is remarkable, ranging from 31% up to 51%. Diverse preoperative risk factors have been documented for patients undergoing cardiac surgery: age, pre-existing cognitive dysfunction, a history of alcohol abuse and the severity of illness at admission.

An early diagnosis of postoperative delirium is of great importance to prevent long-term cognitive impairment. For this purpose, a highly specific diagnostic monitoring tool should be implemented during perioperative cardiac surgery care. Near infrared spectroscopy (NIRS) provides information on brain oxygenation by quantifying the regional cerebral oxygen saturation (SctO2) at the microvascular level. Recently, two studies showed that preoperative cerebral tissue oxygenation was lower in the cohort of patients that developed delirium postoperatively. Nevertheless, these studies did not investigate whether the onset of postoperative delirium coincided with a change of postoperative SctO2. A relationship between delirium and reduced cerebral blood flow has already been suggested. As such, the occurrence of a postoperative decrease of SctO2 might have been overlooked thus far. Hence, Investigators want to conduct a prospective, interventional study to determine the relationship between postoperative SctO2 and the onset of delirium after cardiac surgery.

Conditions

Delirium

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Study group

Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without 'Coronary Artery Bypass Graft' (CABG) surgery)

Group Type: OTHER

Near-Infrared Spectroscopy (NIRS)

Intervention Type: DEVICE

Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation.

Interventions

Near-Infrared Spectroscopy (NIRS)

Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (age ≥ 70 years) undergoing elective on-pump cardiac surgery (i.e. valve replacement with or without Coronary artery bypass graft surgery (CABG))
• Surgery has to be performed under normothermic conditions
• Ability to perform the confusion assessment method for the intensive care unit (CAM-ICU)
• Patients willing to provide written informed consent

Exclusion Criteria

• Age < 70 years
• Off-pump cardiac surgery
• Surgery performed under hypothermic conditions
• Duration before extubation > 36 hours
• Patients with insufficient knowledge of the Dutch language
• Patients using antipsychotics
• Patients with a known history of alcohol abuse (consuming two or more units a day)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Frank Jans

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Jans, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Countries

Belgium

References

Eertmans W, De Deyne C, Genbrugge C, Marcus B, Bouneb S, Beran M, Fret T, Gutermann H, Boer W, Vander Laenen M, Heylen R, Mesotten D, Vanelderen P, Jans F. Association between postoperative delirium and postoperative cerebral oxygen desaturation in older patients after cardiac surgery. Br J Anaesth. 2020 Feb;124(2):146-153. doi: 10.1016/j.bja.2019.09.042. Epub 2019 Dec 18.

Reference Type: DERIVED

PMID: 31862160 (View on PubMed)

Other Identifiers

ZOLDELIRIUM1

Identifier Type: -

Identifier Source: org_study_id