Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01880684
Study type Observational
Source Montreal Heart Institute
Contact
Status Completed
Phase Phase 2
Start date March 2013
Completion date December 2013

See also
  Status Clinical Trial Phase
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Recruiting NCT05557461 - Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?
Withdrawn NCT03246425 - Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study N/A
Completed NCT02721654 - Plasma-Lyte 148® versUs Saline Study Phase 4
Completed NCT02903316 - Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles N/A
Completed NCT03009305 - Cerebral Oximetry in Lower Body Negative Pressure N/A
Completed NCT01456559 - Detection of Hypovolemia Using Pleth Variability Index (PVI) N/A
Completed NCT00380107 - Volume Deficit Prior to Surgery Phase 4
Recruiting NCT06123039 - Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Completed NCT04573842 - Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
Completed NCT05150418 - Supplemental Oxygen in Hypovolemia Phase 1
Completed NCT02961439 - Validation of Epworth Richmond's Echocardiography Education Focused Year N/A
Completed NCT01535703 - Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography N/A
Completed NCT01010022 - Trial of 6% HES130/0.4 Phase 3
Completed NCT04641949 - Methoxyflurane and Fentanyl in LBNP Phase 4
Recruiting NCT03592290 - Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Suspended NCT03736421 - Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
Completed NCT02679625 - Comparison of Non-Invasive Methods of Assessing Fluid Responsiveness in ED and ICU Patients