Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT03963089
This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.
Looking for future studies?
Notify MeUp to 5 year
All sexes
Interventional
Not applicable
Seoul, 03080, South Korea
Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.
The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.
In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.
Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.
With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Set tidal volume to 6mL/kg for 1 minute
Set tidal volume to 10mL/kg for 1 minute
Set tidal volume to 10mL/kg for 1 minute
Administer 10mL/kg of crystalloid for 5 minutes
Time frame: From sternal closure to 5 minutes after fluid loading
Define subject that shows increase of stroke volume index more than 15% after 10mL/kg of fluid loading as fluid responder, otherwise as non-responder
Time frame: From sternal closure to 5 minutes after fluid loading
Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of pulse pressure variation and systolic pressure variation after each change of set tidal volume
Time frame: From sternal closure to 5 minutes after fluid loading
Area under the curve of the receiver-operative characteristic curve for prediction of fluid responder of respiratory variation of aortic blood flow peak velocity measured via transesophageal echocardiography at tidal volume of 10mL/kg
Time frame: From sternal closure to 5 minutes after fluid loading
Compare the range that the prediction of fluid responsiveness is unreliable (grey zone) for each variable in each set tidal volume
Time frame: From start of anesthesia to end of anesthesia
Heart rate determined by electrocardiogram (beats/min)
Time frame: From start of anesthesia to end of anesthesia
Pulse oximetry determined by photoplethysmography (%)
Time frame: From start of anesthesia to end of anesthesia
End-tidal carbon dioxide measured from ventilatory circuit (mmHg)
Seoul National University Hospital
Other
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.
NCT07190924
Hormones, Inflammation
Aryanah, Ariana Governorate, Tunisia
View Trial DetailsNCT03422809
Menstrual Cycle, Micronutrients
State College, Pennsylvania, United States
View Trial DetailsNCT01483781
Cardiovascular Diseases, Diabetes Mellitus
Neuss, Germany
View Trial DetailsNCT07593014
Body Fluid Compartments, Creatine Supplementation
View Trial Details