Validation of a New Method to Measure Cardiac Output: Comparison With Thermodilution

NCT01806467 | Completed

• 1 other identifier: 210107
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Many mini-invasive devices to monitor cardiac output (CO) have been introduced and among them the Pressure Recording Analytical Method (PRAM). The aim of this study is to assess the agreement of PRAM with the intermittent transpulmonary thermodilution (ThD) and continuous pulmonary ThD in measuring CO in hemodynamically unstable patients.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Blant-Altman test and coefficient of error of Cardiac Output measured with PRAM towards that measured with thermodilution

  Agreement between Cardiac Output measured with PRAM and cardiac output measured with thermodilution (both pulmonary and transpulmonary thermodilution) was determined by the Bland-Altman method. The precision of the measurements was given by the limits of agreement (LoA) (±1.96SD) of the mean difference of the methods compared. Upper and lower LoA were calculated as the bias ± 1.96SD. The percentage error was calculated as the LoA of the bias divided by the mean CO from two methods compared. Thirty per cent was considered an a priori criterion of interchangeability.

  Study Period: 9 months

Study Arms (2)

critically ill patients

patients admitted to the medical-surgical ICU

post-cardiac surgical patients

patients admitted to the post-cardiac surgical ICU

Eligibility Criteria

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

Study Population

hemodynamic instability

You may qualify if:

• Hemodynamic instability in:
• septic shock
• pneumonia
• polytrauma
• chronic obstructive pulmonary disease
• heart failure
• post operative cardiosurgical patients

You may not qualify if:

• Atrial fibrillation
• Pacemaker or implantable cardiac defibrillator
• Aortic or mitral valve disease
• Intra-aortic balloon pump

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

AOU Ospedali Riuniti Ancona

Ancona, Ancona, 60126, Italy

Location

Study Officials

• Abele Donati, MD

  UPollitecnicaDM

  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: February 26, 2013
• First Posted: March 7, 2013
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

IT (1)