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CompletedNCT01880684Updated Apr 4, 2014

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

An observational study in Hypovolemia, Cardiac Output, High and Cardiac Output, Low, sponsored by Montreal Heart Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-04.

Sponsored by Montreal Heart Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Hypovolemia
  • Cardiac Output, High
  • Cardiac Output, Low

Keywords

  • Thermodilution
  • Blood Volume
  • Cardiac Output
  • Leg
  • Capnography
  • Blood Pressure
03

In context

Cardiac Output, Low

94 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 45 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Passive Leg Rising
06

What researchers measure

Primary outcomes

  1. Correlation between elevation in ETCO2 and cardiac output during a reversible fluid challenge, a passive leg raise

    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

    Time frame: Participants will be followed from their arrival in the operating room until 2 hours post-operatively in the intensive care unit

Secondary outcomes

  1. 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

  2. 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

  3. 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

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Study locations

1 site
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
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References and documents

Publications

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  • McLean AS, Huang SJ, Kot M, Rajamani A, Hoyling L. Comparison of cardiac output measurements in critically ill patients: FloTrac/Vigileo vs transthoracic Doppler echocardiography. Anaesth Intensive Care. 2011 Jul;39(4):590-8. doi: 10.1177/0310057X1103900409. PubMed 21823375 ↗
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  • Biais M, Vidil L, Sarrabay P, Cottenceau V, Revel P, Sztark F. Changes in stroke volume induced by passive leg raising in spontaneously breathing patients: comparison between echocardiography and Vigileo/FloTrac device. Crit Care. 2009;13(6):R195. doi: 10.1186/cc8195. Epub 2009 Dec 7. PubMed 19968880 ↗
  • Mutoh T, Ishikawa T, Kobayashi S, Suzuki A, Yasui N. Performance of Third-generation FloTrac/Vigileo system during hyperdynamic therapy for delayed cerebral ischemia after subarachnoid hemorrhage. Surg Neurol Int. 2012;3:99. doi: 10.4103/2152-7806.100195. Epub 2012 Aug 27. PubMed 23061015 ↗
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  • Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06. PubMed 16540963 ↗
  • Preau S, Saulnier F, Dewavrin F, Durocher A, Chagnon JL. Passive leg raising is predictive of fluid responsiveness in spontaneously breathing patients with severe sepsis or acute pancreatitis. Crit Care Med. 2010 Mar;38(3):819-25. doi: 10.1097/CCM.0b013e3181c8fe7a. PubMed 20016380 ↗
  • Monnet X, Teboul JL. Passive leg raising. Intensive Care Med. 2008 Apr;34(4):659-63. doi: 10.1007/s00134-008-0994-y. Epub 2008 Jan 23. PubMed 18214429 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01880684
Lead sponsor
Montreal Heart Institute
Responsible party
Andre Denault (MD FRCPC ABIM-CCM, Montreal Heart Institute) — Principal investigator
First posted
Jun 19, 2013
Start date
Mar 2013
Primary completion
Sep 2013
Completion
Dec 2013
Last update
Apr 4, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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