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

Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03136614
• Other study ID #: Arteriograph-2016
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: August 29, 2017
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia

Intervention

Device:
• Arteriograph

Locations

Country	Name	City	State
Hungary	Department of Anaesthesiology and Intensive Therapy	Szeged	Csongrád

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Correlation between systemic vascular resistance and aortic augmentation index		One year
Primary	Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph		One year