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

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.

Study Overview

• Status: Unknown
• Conditions: Anaesthesia
• Intervention / Treatment: Device: Arteriograph

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6725
      • Recruiting
      • Department of Anaesthesiology and Intensive Therapy
      • Contact: Petra Dalmann; Phone Number: +36 62 - 545 168; Email: office.aiti@med.u-szeged.hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Arteriograph-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES