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Clinical Trials/NCT03136614
NCT03136614UnknownNot Applicable

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

Szeged University2 sites in 1 country30 target enrollmentStarted: June 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
Correlation between systemic vascular resistance and aortic augmentation index

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Correlation between systemic vascular resistance and aortic augmentation index

Time Frame: One year

Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph

Time Frame: One year

Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity.

Time Frame: One year

The investigators will examine if high values of pulse wave velocity correlate with the frequency and severity of hypotensive episodes under anaesthesia.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Szeged University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zsolt Molnár, MD, PhD, DEAA

clinician

Szeged University

Study Sites (2)

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