Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit

Study Overview
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Brief Summary
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To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.

Official Title
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Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit

Conditions
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Anaesthesia

Intervention / Treatment
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* Device: Arteriograph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the preoperative arm: Signed informed consent form Arterial catheter for hemodynamic monitoring For the intraoperative arm: Signed informed consent form Arterial catheter for hemodynamic monitoring The operation will presumably last for more than 2 hours For the intensive care unit arm: Signed informed consent form PiCCO monitor for hemodynamic monitoring Exclusion Criteria: For the preoperative arm: Pregnancy Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student For the intraoperative arm: Pregnancy Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student Measuring blood pressure on both arms is not possible Insertion of an arterial catheter is not necessary or contraindicated Insertion of a central venous catheter is not necessary or contraindicated For the intensive care unit arm: Pregnancy Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative<br>A single measurement with an Arteriograph is performed a day before an elective surgical intervention. | Device: Arteriograph<br> <br> |
| Active Comparator: Intraoperative<br>An arteriograph is put on the patient for the time of operation. The device is set to measure in every 5 minutes. | Device: Arteriograph<br> <br> |
| Active Comparator: Intensive Care Unit<br>Three separate measurements are performed on the subject with an Arteriograph throughout every dayshift for 3 days. | Device: Arteriograph<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity. | The investigators will examine if high values of pulse wave velocity correlate with the frequency and severity of hypotensive episodes under anaesthesia. | One year | 
| Correlation between systemic vascular resistance and aortic augmentation index |  | One year | 
| Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph |  | One year |