Arterial Tone Influence on Cardiac Output Measured by PRAM

NCT03900546 | Completed

• 1 other identifier: PRAM
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the role of arterial tone in the accuracy of cardiac output (CO) measurement by Pressure Recording Analytical Method (PRAM). Patients receiving noradrenaline who need for clinical reason to change the noradrenaline dose will be enrolled. We use echocardiography as reference method of CO measurement.

Conditions

Cardiac Output; Critically Ill

Outcome Measures

Primary Outcomes (1)

• Changes of cardiac output after variation of noradrenaline dose: ECO versus PRAM

  Agreement between echocardiography and PRAM in CO measurement during arterial tone changes induced by different dose of noradrenaline

  Before and 30 minutes after noradrenaline dose variation

Interventions

MostCare DEVICE

CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients admitted to intensive care unit that need variation of noradrenaline dose for clinical reason.

You may qualify if:

• invasive blood pressure monitoring on site
• need to start or change the dose of noradrenaline infusion for clinical reason

You may not qualify if:

• age \<18
• arrhythmia
• severe valvular insufficiency
• pregnancy
• low quality arterial signal

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

Ancona, Italy

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abele Donati, MD, PhD

  Università Politecnica delle Marche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 3, 2019
• Study Start: March 1, 2014
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)