Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 30, 2017
August 1, 2017
1.5 years
February 20, 2017
August 29, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
Preoperative
ACTIVE COMPARATORA single measurement with an Arteriograph is performed a day before an elective surgical intervention.
Intraoperative
ACTIVE COMPARATORAn arteriograph is put on the patient for the time of operation. The device is set to measure in every 5 minutes.
Intensive Care Unit
ACTIVE COMPARATORThree separate measurements are performed on the subject with an Arteriograph throughout every dayshift for 3 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6725, Hungary
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinician
Study Record Dates
First Submitted
February 20, 2017
First Posted
May 2, 2017
Study Start
June 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
August 30, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share