Arterial Tone Influence on Cardiac Output Measured by PRAM

NCT ID: NCT03900546

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pressure Recording Analytical Method (PRAM) is an arterial pulse contour analysis method for CO measurement. As it is an uncalibrated method, one possible reason for its inaccuracy is rapid changes in arterial tone.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Output Critically Ill

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MostCare

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* age \<18
* arrhythmia
* severe valvular insufficiency
* pregnancy
* low quality arterial signal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università Politecnica delle Marche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abele Donati, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abele Donati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università Politecnica delle Marche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

Ancona, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRAM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.