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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05220696
Other study ID # RECHMPL22_0003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date October 20, 2020

Study information

Verified date January 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The optimal management of shock states requires a precise evaluation of several parameters, clinical, biological, hemodynamic, and echocardiographic. Among these, parameters that measure O2 and CO2 consumption are of a great interest, especially PCO2 arteriovenous gradient (PCO2 gap) and O2 arteriovenous difference [D(a-v) O2]. The PCO2 gap best correlates with cardiac output while the PCO2gap/D(a-v)O2 ratio would be earlier and more specific than blood lactate assay in assessing tissue hypoperfusion secondary to shock. The PCO2 gap and the PCO2gap/D (a-v) O2 ratio have been evaluated from gas measurements of venous blood collected from the pulmonary artery and from the superior vena cava area. However, in some patients the placement of a catheter in the superior vena cava is difficult or even impossible due to thrombosis, vascular occlusions and other reasons… In these cases, the inferior vena cava is used for drugs infusion, nutrition and possibly samples. Gasometric samples in lower cellar territory have not yet been validated and may not be correlated with measurements in upper cellar territory. It is therefore useful for current practice to validate samples in lower cellar territory and demonstrate their correlation with measurements made in upper cellar territory. During an observation period, in patients with catheters in the superior and inferior vena cava for therapeutic indications (renal replacement therapy,...), the investigators systematically took gas measurements at the femoral and jugular sites. the investigators used these data to assess the correlation of PCO2 gap measurements and carbon dioxide-derived indices according to the harvest site : jugular and femoral venous.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date October 20, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - All consecutive critically ill patients who had an arterial catheter and a venous catheter in the superior and inferior vena cava were included. Exclusion criteria: - An age under 18 - Pregnancy - Legally protected adults

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The correlation of the measurement of indices derived from carbon dioxide (CO2) To assess the correlation of the measurement of indices derived from carbon dioxide (CO2) according to the femoral or jugular harvest site in the critically ill patient. Measurements included venous pCO2 and pO2, and central venous saturation ; arterial pO2 and pCO2.
From these measurements, carbon dioxides and oxygen variables were calculated as follows :
PCO2gap= Pv-aCO2= PvCO2 -PaCO2, where PaCO2 and PvCO2 represent their arterial and venous partial pressures respectively D(a-v)O2= CaO2- CvO2= [(hg x SaO2 x 1.34) + (Pa02 x O.OO3)]- [(hg x SvO2 x 1.34) + (Pv02 x O.OO3)], where CaO2 and CvO2 are the arterial and venous 02 content, PaO2 and PvO2 represent their arterial and venous partial pressures respectively.
Venous measurements are realized in both venous jugular and femoral sites.
day 1
Secondary To assess the correlation of the measurement of venous O2 saturation To assess the correlation of the measurement of venous O2 saturation according to the femoral or jugular harvest site. To find a simple equation allowing to calculate the gasometric parameters superior vena cava PCO2 gap and ratio PCO2gap / D (a-v) O2 from measurements made at the femoral level day 1
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