Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac
NCT ID: NCT01880684
Last Updated: 2014-04-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2013-03-31
Study Completion Date
2013-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Hypovolemia
Cardiac Output, High
Cardiac Output, Low
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Passive Leg Rising
No interventions assigned to this group
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Montreal Heart Institute
OTHER
Sponsor Role
lead
Responsible Party
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Andre Denault
MD FRCPC ABIM-CCM
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Montreal Heart Institute
Montreal, Quebec, Canada
Site Status
Countries
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Canada
References
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Other Identifiers
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13-1437
Identifier Type: -
Identifier Source: org_study_id
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