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

Neurological Outcome Clinical Trial

— CSINVOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412619
• Other study ID #: CTC-A 11-131 CSINVOS
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: December 24, 2011
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurological Outcome

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire	CAM-ICU Quesionnaire is used to assess the patient´s ability of postoperative orientation, to detect and treat changes between preoperative and postoperative questionnaires and therefore a potential postoperative delirium earliest possible.	Changes between 6 - 48 hours before surgery and 12 hours after surgery	No
Secondary	MIF (Macrophage Migration Inhibitory Factor)	MIF is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.	Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.	No
Secondary	Cytokine IL-6	Cytokine IL-6 is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.	Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.	No
Secondary	Cytokine IL-10	Cytokine IL-10 is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.	Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.	No
Secondary	Procalcitonin (PCT)	PCT is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.	Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.	No
Secondary	S-100 Protein	S-100 Protein is used as inflammatory marker to ensure an uncomplicated postoperative period and to be able to react appropiately in case of values outsite expected range.	Preoperative (2-30 minutes) after induction of anaesthesia, but (2-30 minutes) before starting surgery and postoperative immediately after admission to ICU, 4 hours after admission and every further morning in ICU in context of routine blood tests.	No
Secondary	SOFA-Score (Sequential Organ Failure Assessment score)	The SOFA score is used to track a patient's status during the stay in the ICU	12 hours after surgery	No