Use of Exhaled Carbon Dioxyde for Monitoring the Native Cardiac Function During Mechanical Circulatory Support With Venoarterial By-pass in Intensive Care Unit (CAPNOECMO)
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|ClinicalTrials.gov Identifier: NCT03323268|
Recruitment Status : Completed
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment|
|Residual Cardiac Output During PVA-ECMO||Device: PetCO2 monitoring|
This prospective study is conducted since January 2016 in our tertiary ICU and has been approved by our hospital's institutional review board. Informed consent will be obtained from all patients or their surrogates.
Hemodynamic is monitored via a radial arterial catheter for continuous blood pressure monitoring, a pulmonary artery catheter (Swan-Ganz CCOmbo® CCO/SvO2, Edwards Lifesciences) inserted through the superior vena cava (jugular intern or subclavian vein) and transoesophageal echocardiography (TOE) at PVA-ECMO implantation or at operator discretion.
ECMO circuit settings and patients management under ECMO
PVA-ECMO consist of polyvinyl chloride tubing with a membrane oxygenator (PH.I.S.I.O and EOS; Sorin Group, Clamart, France), a centrifugal pump (Stockert; Sorin Group), and percutaneous or surgically inserted arterial and venous femoral cannulae (Fem-Flex and Fem-Track, Edwards Life- sciences, Guyancourt, France) with or without an additional 7 F cannula inserted distally into the femoral artery to prevent lower limb ischemia. An oxygen-air blender (Sechrist Industries, Anaheim, CA) ventilate the membrane oxygenator. Unfractionated heparin is administrated to maintain an activated partial thromboplastin time between 1.5 and 2 times the normal value. The lower speed flow necessary for adequate tissue perfusion is wanted.
Ventilator settings, end-tidal PCO2 monitoring, blood gas analysis and transpulmonary blood flow monitoring
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Validation of End-tidal CO2 for Transplumonary Blood Flow Monitoring During PVA-ECMO|
|Actual Study Start Date :||January 12, 2016|
|Actual Primary Completion Date :||October 23, 2016|
|Actual Study Completion Date :||October 23, 2017|
- Device: PetCO2 monitoring
CO2 analyzer on ventilator expiratory lane. On-line, continuous, and noninvasive monitor. Routine use in anesthesia and intensive care units.
- Assessment of end-tidal pressure CO2 (PetCO2) correlation with pulmonary artery flow [ Time Frame: Up to 5 days ]end-tidal pressure CO2 (PetCO2) vs pulmonary artery flow measured by pulmonary catheter or echocardiography
- Assessment of end-tidal pressure CO2 (PetCO2) thresholds to detect pulmonary artery flow < 1 l/min and indexed flow < 1l/min/m2 [ Time Frame: Up to 5 days ]
- Assessment of Factors of end-tidal pressure CO2 (PetCO2) variation [ Time Frame: Up to 5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323268
|Montpellier, France, 34295|