A Non Invasive Estimation of Cardiac Output in Mechanically Ventilated Patients

NCT01714258 | Completed DMC

• 1 other identifier: CaraMat
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The two gold standard for cardiac output (CO) measurements, i.e., the Fick method and pulmonary artery thermodilution , are both invasive methods, requiring the use of central venous catheter and Swan-Ganz catheter, respectively. With the aim to reduce the risks for the patient, a big research effort has been made to investigate minimally invasive or non-invasive methods. Investigators sought to evaluate the effectiveness of a non invasive method to estimate CO in mechanically ventilated patients.The method is based on prolonged expiration, and relies on measurement of gas concentrations and flow rate. Investigators designed, realized, and characterized a system to induce passive prolonged expirations when connected to the patient circuit. CO is then calculated using an algorithm based a modified version of the Fick equation and the results are compared with the ones obtained by thermodilution. Several advantages can be introduced by the prolonged expiration technique: non-invasive measurement, easy implementation, independency from operator ability among others.

Conditions

Non Invasive Estimation of Cardiac Output

Keywords

cardiac output; fick method; thermodilution

Outcome Measures

Primary Outcomes (1)

• A non invasive method to estimate cardiac output in mechanically ventilated surgery based on prolonged expiration and its outcome is compared to the values obtained from the invasive measurement system based on thermodilution.

  To obtain cardiac output for each patient,throughout a period of about 45 min, thermodilution was executed 10 times, and prolonged expiration 20 times.

  within the first day after surgery

Study Arms (1)

non invasive cardiac output measure

EXPERIMENTAL

non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients 20 times, throughout a period of about 45 min

Procedure: cardiac output measurement

Interventions

cardiac output measurement PROCEDURE

non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients

non invasive cardiac output measure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postoperative cardiac surgery patients mechanically ventilated after surgery

You may not qualify if:

• Patients who were hemodynamically unstable requiring high doses of vasoactive medications, fluids or colloidal solutions to maintain their pressure
• Patients who require inspired oxygen concentration higher than 60%.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

University Hospital Campus Biomedico

Rome, Rome, 000128, Italy

Location

Related Publications (1)

• Cecchini S, Schena E, Notaro M, Carassiti M, Silvestri S. Non-invasive estimation of cardiac output in mechanically ventilated patients: a prolonged expiration method. Ann Biomed Eng. 2012 Aug;40(8):1777-89. doi: 10.1007/s10439-012-0534-3. Epub 2012 Feb 24.

  PMID: 22361831 RESULT

Study Officials

• massimiliano carassiti, prof

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 25, 2012
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

IT (1)