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NCT Number: NCT01412619

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

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).

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Key information

Conditions

Neurological Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Aachen

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) Questionnaire

    Time frame: Changes between 6 - 48 hours before surgery and 12 hours after surgery

    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.

Secondary outcomes

  1. MIF (Macrophage Migration Inhibitory Factor)

    Time frame: 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.

    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.

  2. Cytokine IL-6

    Time frame: 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.

    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.

  3. Cytokine IL-10

    Time frame: 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.

    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.

  4. Procalcitonin (PCT)

    Time frame: 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.

    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.

  5. S-100 Protein

    Time frame: 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.

    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.

  6. SOFA-Score (Sequential Organ Failure Assessment score)

    Time frame: 12 hours after surgery

    The SOFA score is used to track a patient's status during the stay in the ICU

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: CSINVOS

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 9, 2011
Registry last updated
Dec 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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