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

Not Applicable

• Conditions: Anaesthesia

• Registration Number: NCT03136614
• Lead Sponsor: Szeged University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity.	One year	The investigators will examine if high values of pulse wave velocity correlate with the frequency and severity of hypotensive episodes under anaesthesia.

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Therapy; 🇭🇺 Szeged, Csongrád, Hungary