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Trial record 34 of 857 for:    CARBON DIOXIDE AND arterial

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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date July 12, 2016
First Posted Date October 26, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date January 12, 2016
Actual Primary Completion Date October 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 25, 2017)
  • 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 ]
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 Use of Exhaled Carbon Dioxyde for Monitoring the Native Cardiac Function During Mechanical Circulatory Support With Venoarterial By-pass in Intensive Care Unit
Official Title Validation of End-tidal CO2 for Transplumonary Blood Flow Monitoring During PVA-ECMO
Brief Summary Cardiogenic shock, the most severe form of acute heart failure, is a critical situation where the body cells lack of oxygen because of cardiac dysfunction. The failure of pharmacological therapy to maintain adequate perfusion has led to attempts to improve the circulation by the use of mechanical circulatory support devices. Peripheral veno-arterial support (PVA-ECMO) is the most frequently used device. It consists of extracorporeal circulatory support. Venous blood is aspirated via the right atrium and reinjected into the descending aorta via the femoral artery. As a consequence of this by-pass, pulmonary artery flow and residual left ventricle ejection can fall drastically until zero in the most severe patients. A minimal transpulmonary blood flow is crucial to avoid left heart cavities and pulmonary artery and left heart cavities thrombosis. The gold standard technique to monitor transpulmonary blood flow is right-heart cavities catheterism (Swan-Ganz catheter) but it represents major limits: invasive technique, limited duration of utilization because of septic risk, physical limit of flow measurement (under 1 liter/minute). End-tidal pressure carbon dioxide (Pet CO2) monitoring (or capnography) is a routine and non-invasive measure in ventilated patients. Previous studies have shown that changes in PetCO2 can measure changes in cardiac output in anesthetized patients and that PetCO2 is a useful index of pulmonary artery blood flow during separation from cardiopulmonary bypass. The aim of this study is to demonstrate that PetCO2 is correlated to transpulmonary blood flow in patients under PVA-ECMO and that exhaled CO2 can provide an on-line, continuous, and noninvasive monitor of residual outflow from the heart during PVA-ECMO.
Detailed Description

Settings

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
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 under mechanical ventilation and PVA-ECMO support
Condition Residual Cardiac Output During PVA-ECMO
Intervention Device: PetCO2 monitoring
CO2 analyzer on ventilator expiratory lane. On-line, continuous, and noninvasive monitor. Routine use in anesthesia and intensive care units.
Study Groups/Cohorts Not Provided
Publications * Mourad M, Eliet J, Zeroual N, Saour M, Sentenac P, Manna F, Molinari N, Gandet T, Colson PH, Gaudard P. Pulse pressure and end-tidal carbon dioxide for monitoring low native cardiac output during veno-arterial ECLS: a prospective observational study. Crit Care. 2020 Sep 22;24(1):569. doi: 10.1186/s13054-020-03280-z.

*   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: October 25, 2017)
39
Original Actual Enrollment Same as current
Actual Study Completion Date October 23, 2017
Actual Primary Completion Date October 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients under mechanical ventilation and PVA-ECMO support with low residual native cardiac output

Exclusion Criteria:

  • age less than 18 years
  • pulmonary disorders with abnormal dead-space (obstructive pulmonary disease; acute respiratory distress syndrome)
  • cardiac shunt (atrial or ventricular communication)
  • significant tricuspid or pulmonary valve disease
  • pulmonary artery catheter implantation contraindicated.
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 France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03323268
Other Study ID Numbers 9653
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: unkown
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Montpellier
Verification Date July 2016