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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01880684
First received: June 7, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Phase
Hypovolemia
Cardiac Output, High
Cardiac Output, Low
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Passive Leg Rising

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01880684

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
  More Information

Publications:
Kusaka Y et al. Clinical comparison of an echocardiograph-derived versus pulse counter-derived cardiac output measurement in abdominal aortic aneurysm surgery. J Cardiothorac Vasc Anesth. 2012 Apr; 26(2):223-6.

Responsible Party: Andre Denault, MD FRCPC ABIM-CCM, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01880684     History of Changes
Other Study ID Numbers: 13-1437
Study First Received: June 7, 2013
Last Updated: April 3, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
Thermodilution
Blood Volume
Cardiac Output
Leg
Capnography
Blood Pressure

Additional relevant MeSH terms:
Cardiac Output, Low
Cardiac Output, High
Hypovolemia
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014