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

University of Szeged (SZTE)

Status: Unknown

Conditions: Anaesthesia

Treatments: Device: Arteriograph

Study type: Interventional

Funder types: Other

Identifiers

NCT03136614

Arteriograph-2016

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Preoperative

Active Comparator group

Description:

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

Treatment:

Device: Arteriograph

Intraoperative

Active Comparator group

Description:

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

Treatment:

Device: Arteriograph

Intensive Care Unit

Active Comparator group

Description:

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

Treatment:

Device: Arteriograph