Non-invasive Measurement of Regional Intracerebral Tissue Oxygenation in Elective Cardiac Surgeries

NCT ID: NCT01412619

Last Updated: 2011-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-12-31

Brief Summary

Patients after cardiac surgical operations often exhibit neuropsychological complications. In particular, the post-operative delirium is associated with a significantly increased morbidity and mortality.

Intracerebral microembolization in addition to inadequate cerebral perfusion during surgery was verified as the main cause of this.

The aim of the study is to demonstrate a correlation between intraoperative low measured cerebral oxygen levels and a loss neurological outcome, especially the development of postoperative delirium, using non-invasive cerebral oximetry (RSO2).

Detailed Description

Before the operation, the parameters required for the collection of the EURO-scores are recorded, allowing an assessment of perioperative risk (age, gender, type of planned surgery, concomitant diseases).

After the patient arrives in the operating room the required electrodes to measure the intracerebral oxygenation are stuck bitemporal on the patient´s head. The measurement of oxygenation begins before induction of anaesthesia (while the patient is still awake) and will continue until 24 h postoperatively.

The measurement of cerebral oxygenation is not intended to serve as a replacement for the collection of routine peripheral oxygen saturation, but will be performed additionally.Therefore the anaesthesiological management depends primarily on the peripheral oxygen saturation and arterial blood gases according to our clinical routine.

If, however, intracerebral oxygenation shows an ominous decline, this change can be corrected by targeted measures very early (such as increasing the inspiratory oxygen concentration). At the specified test points following additional parameters are determined: Mean arterial blood pressure, central venous blood pressure, cardiac output, serum lactate, venous oxygen saturation, arterial blood gas analysis, fluid balance. These parameters are collected as part of a routine cardiac surgery. To measure these parameters no additional punctuation or blood draws are therefore necessary. To determine the cytokines IL-6 and IL-10, procalcitonin (PCT) and the S-100 protein, however, it is necessary to take 5ml blood to the respective measuring points from an already existing venous access.

In the ICU the collection of the above mentioned parameters occurs at admission, after 6h and 12h, and on the morning of the first postoperative day (and possibly on further ICU-treatment-days). Additionally, each 12 h after surgery, the SOFA and the CAM-ICU-Score are recorded.

An already before surgery performed CAM-ICU questionnaire serves as a direct comparison with the post-operative acquired CAM-ICU score. In case the patient is still be ventilated, the test cannot be performed and will be documented correspondingly.

The treatment, monitoring of vital signs including intermittent blood gas analysis and other diagnostic measures (clinical chemistry, radiology, etc.) corresponds to the standard surgical procedure for heart surgery of the University Hospital Aachen.

Conditions

Neurological Outcome

Keywords

Neurological Outcome; Intraoperative intracerebral Oxygen level; Mean arterial blood pressure; Central venous blood pressure; Cardiac output; Serum Lactate; Venous oxygen saturation; Fluid balance

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age of 18 years or older
• Elective cardiac surgery at heart-lung-machine

Exclusion Criteria

• Pregnancy or lactation period
• Patients not capable of consenting
• Emergency surgery
• Patients under 18 years
• Known depression

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Clinic for Anaesthesiology, Clinical Trial Center Aachen

Locations

University Hospital Aachen

Aachen, , Germany

Countries

Germany

References

Stoppe C, Fries M, Rossaint R, Grieb G, Coburn M, Simons D, Brucken D, Bernhagen J, Pallua N, Rex S. Blood levels of macrophage migration inhibitory factor after successful resuscitation from cardiac arrest. PLoS One. 2012;7(4):e33512. doi: 10.1371/journal.pone.0033512. Epub 2012 Apr 10.

Reference Type: DERIVED

PMID: 22506003 (View on PubMed)

Other Identifiers

CTC-A 11-131 CSINVOS

Identifier Type: -

Identifier Source: org_study_id