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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

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.

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Detailed Description

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Conditions

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Anaesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Preoperative

A single measurement with an Arteriograph is performed a day before an elective surgical intervention.

Group Type ACTIVE_COMPARATOR

Arteriograph

Intervention Type DEVICE

Intraoperative

An arteriograph is put on the patient for the time of operation. The device is set to measure in every 5 minutes.

Group Type ACTIVE_COMPARATOR

Arteriograph

Intervention Type DEVICE

Intensive Care Unit

Three separate measurements are performed on the subject with an Arteriograph throughout every dayshift for 3 days.

Group Type ACTIVE_COMPARATOR

Arteriograph

Intervention Type DEVICE

Interventions

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Arteriograph

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes