Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac

April 3, 2014 updated by: Andre Denault, Montreal Heart Institute

The aim of this study is to evaluate the correlation of capnography with non-invasive measurement of cardiac output with the FloTrac/EV1000 following a reversible fluid challenge, a passive leg raising maneuver, using thermodilution as the gold standard.

The main hypothesis is a correlation of 0.8 between the increasing of ETCO2 and the increasing of ejection volume measured by FloTrac/EV1000 following a passive leg raising maneuver.

Study Overview

Status

Completed

Conditions

Detailed Description

Data are collected on past medical illnesses, medication, type of surgery, abnormalities on pre-operative transesophageal echocardiogram and localisation of arterial line.

Before induction of anesthesia, an arterial line is installed. The agents of induction of anesthesia and doses are left to the discretion of the attending anesthesiologist. The trachea is intubated, anesthesia circuit and sidestream CO2 sensor were connected to the endotracheal tube and positive pressure ventilation begins with standardized parameters: control assisted mode with no inspiratory effort, tidal volume of 6-8 mL/kg, respiratory rate of 8-10/minute and PEEP of 5 mmHg. Modification of the ventilation parameters is not permitted before and during the PLR maneuvers. Isoflurane and propofol are used for the maintenance of anesthesia. A PA catheter (Paceport, Edwards Lifesciences, Irvine, California, USA) is inserted in the right internal jugular vein. If a femoral line is installed, the FloTrac/EV1000 is connected to the femoral line, if not, the radial line is used for mini-invasive continuous cardiac output monitoring. The a and v wave aspect and ratio of CVP waveform is noted. The RV waveform is inspected for signs of abnormalities such as a non-horizontal slope restrictive pattern (Figure xx)18. The transducers are all placed at the midthoracic level and a "flush test" is performed prior to CO measurements with the FloTrac/EV1000 to ensure absence of resonance or damping of the system.

At baseline, in the operating room before the first PLR maneuver, the heart rate, systolic, diastolic and mean arterial pressure, CVP value, CI measured in triplicate with the thermodilution method and the FloTrac derived variables are recorded. These variables include the CO indexed CO and SVV measured by the FloTrac/EV1000. The same variables are recorded at 1, 3 and 5 minutes after the beginning of PLR except CI by thermodilution which is measured again only once, at 3 minutes and EtCO2 which is recorded every 12 seconds. The EtCO2 curve is inspected at baseline and during the PLR maneuver to ensure the changes in EtCO2 were not related to changes in inspired CO2, ventilator or circuit malfunction or increase in airway resistance.

After weaning from CPB, the same measures are taken twice: with chest opened, when hemodynamic stability is achieved, and CPB canulas taken out and with chest closed.

In the ICU, two additional PLR maneuvers were executed with a 30 minutes interval in between. The set of measurements previously described are recorded. The use of an epicardial temporary pacemaker, vasopressors (doses and type), vasodilators (doses and type) are also recorded.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of 18 years old or more presenting for cardiac or aortic surgery at the Montreal Heart Institute.

Description

Inclusion Criteria:

  • 18 years old or more who have cardiac or aortic surgery

Exclusion Criteria:

  • Pacemaker
  • Lower limb amputation or absence of lower limb
  • Moderate tricuspid insufficiency
  • Preoperative arrythmia or prolonged arrythmia during data measurements
  • Moderate aortic regurgitation
  • Known deep vein thrombosis
  • Intra-aortic balloon pump

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Passive Leg Rising

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between elevation in ETCO2 and cardiac output during a reversible fluid challenge, a passive leg raise
Time Frame: Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit
Correlation of 0.8 between the increase of ETCO2 and the increase of ejection volume measured by FloTrac/EV1000 following a passive leg raising maneuver
Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between changes in indexed cardiac output measured by Flotrac/EV1000 and by thermodilution during a reversible fluid challenge, a passive leg raise
Time Frame: Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit
Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit
Correlation between elevation in capnography and indexed cardiac output measured by thermodilution during a reversible fluid challenge, a passive leg raise
Time Frame: Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit
Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit
Correlation between changes in capnography and indexed cardiac output measured by Flotrac/EV1000 during a reversible fluid challenge, a passive leg raise
Time Frame: Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit
Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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