Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04889807 |
Other study ID # |
PO21031* |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 5, 2021 |
Est. completion date |
August 1, 2021 |
Study information
Verified date |
March 2022 |
Source |
CHU de Reims |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not
totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and
increase post operative respiratory complications. Furthermore, fluid administration is not
always followed by a cardiac output increase.
Predicting preload responsiveness before administering fluid by reliable and reproductible
methods is necessary in critically ill patients.
Dynamic indicators are approved at the bedside such as passive raising leg test, pulse
pressure variation, respiratory variation of the diameter of the superior vena cava. However,
all these tests cannot be used for all patients. For example in the cases of spine or pelvis
injury, or traumatic brain injury, patients with difficult condition for transthoracic
echography.
The investigators hypothesize that EtCO2 (end tidal carbon dioxide) variation after an 15
seconds end-expiratory occlusion test could predict fluid responsiveness in mechanically
ventilated patients in the intensive care units.
EtCO2 is a parameter which can be easy to collect, reproductible, and totally non invasive.
This method could be especially appropriate for patients for whom the classical test of fluid
responsiveness cannot be used
Description:
For each patient under mechanical ventilation, answering inclusions and non inclusions
criteria, and eligible to a fluid perfusion, the physician in charge collect vital parameters
such as cardiac frequency, blood pressure, cardiac output and end tidal carbon dioxide.
The cardiac output is measured by transthoracic echography, or invasive devices such as
transpulmonary thermodilution or pulmonary arterial catheter.
The physician achieve a 15 seconds interruption of mechanical ventilation at end expiration,
and collect the end tidal carbon dioxide variation.
Fluid perfusion of 500 ml of crystalloid is performed. Then the physician collect the same
vital parameters, including a new cardiac output measure.
The patients for whom the cardiac output increased about more than 15 percent are considered
as responders, the others are considered as non responders.
Furthermore, socio demographic parameter, reason for admission, parameters of mechanical
ventilation, use of vasopressor drugs and water balance are collected.