Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 85340 for:    measured

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880684
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute

Tracking Information
First Submitted Date June 7, 2013
First Posted Date June 19, 2013
Last Update Posted Date April 4, 2014
Study Start Date March 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2013)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 14, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac
Official Title Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac
Brief 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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Hypovolemia
  • Cardiac Output, High
  • Cardiac Output, Low
Intervention Not Provided
Study Groups/Cohorts Passive Leg Rising
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 14, 2013)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01880684
Other Study ID Numbers 13-1437
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andre Denault, Montreal Heart Institute
Study Sponsor Montreal Heart Institute
Collaborators Not Provided
Investigators Not Provided
PRS Account Montreal Heart Institute
Verification Date April 2014