CHU
Clermont-Ferrand, France
NCT Number: NCT04399278
The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
The reduction of postoperative complications is an essential aspect of care in perioperative medicine.
Many studies have shown that individualized hemodynamic therapy, by optimizing fluid administration and cardiac output, can reduce the risk of postoperative morbidity and mortality.
A fluid challenge, consisting in the administration of a small bolus of intravenous volume of fluid over a short period of time, is one of the commonest therapeutic hemodynamic intervention to test the preload reserve and the cardiac response to an increase in intravascular volume of a patient (fluid responsiveness). However, an increase in stroke volume (or cardiac output) is only achieved in 30 to 50% of patients after a fluid challenge test. Several dynamic tests have been described to predict the response to fluid challenge, however their limits are numerous.
The end-expiratory occlusion (EEO) test, consisting in a brief interruption of mechanical ventilation at end-expiration, by preventing the variation in intra-thoracic pressure, allows an increase in venous return, cardiac preload and stroke volume. Thus, an increase in stroke volume during an EEO can predict fluid responsiveness, simulating a fluid challenge though avoiding the administration of possibly unnecessary fluids.
The EEO test has already been successfully evaluated in several studies in ICU patients. Only few studies were conducted in the operating room, with conflicting findings: one study, consisting of an EEO test of 30 seconds found that changes in stroke volume during an EEO can predict fluid responsiveness, whereas another one, consisting of an EEO test of 15 seconds did not.
The purpose of the study is to evaluate the influence of the duration of EEO test to predict fluid responsiveness in mechanically ventilated patients in operating room.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A set of respiratory and hemodynamic measurements (including cardiac output) will be recorded at each stage:
A first set of measurements will be performed after intubation (before the surgical incision) and will be repeated, if necessary, in case of further decrease in stroke volume during surgery or in case of any clinical indication of volume expansion (i.e., arterial persistent hypotension, major hemorrhage, etc.).
Time frame: During surgery
Comparison of the areas under the ROC (Receiver Operating Characteristic) curves.
University Hospital, Clermont-Ferrand
Other
End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)
Acronym: EXPIRE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05708638
General Anesthesia, Hemodynamic Instability
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT04137991
Cardiac Surgery, General Anesthesia
Brussels, Belgium
View Trial DetailsNCT04792814
Hemodynamic Instability, Surgery
Kiel, Deutschland (deu), Germany
View Trial DetailsNCT03808753
Anesthesia, Hemodynamic Instability
Rozzano, Milano, Italy
View Trial Details