Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children
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|ClinicalTrials.gov Identifier: NCT03963089|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plasma Volume Tidal Volume||Procedure: Tidal volume_6mL/kg Procedure: Tidal volume_10mL/kg Procedure: Tidal volume_14mL/kg Procedure: Fluid loading||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||March 1, 2020|
Experimental: Study group
Measure pulse pressure variation and systolic pressure variation after each set of tidal volume to 6mL/kg, 10mL/kg and 14mL/kg. Measure respiratory variation of aortic blood flow peak velocity via transesophageal echocardiography at tidal volume of 10mL/kg.
Measure stroke volume index via transesophageal echocardiography before and 5 min after fluid loading with 10mL/kg of crystalloid.
Procedure: Tidal volume_6mL/kg
Set tidal volume to 6mL/kg for 1 minute
Procedure: Tidal volume_10mL/kg
Set tidal volume to 10mL/kg for 1 minute
Procedure: Tidal volume_14mL/kg
Set tidal volume to 10mL/kg for 1 minute
Procedure: Fluid loading
Administer 10mL/kg of crystalloid for 5 minutes
- Stroke volume index [ 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
- Predictability_PPV and SPV [ 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
- Predictability_△Vpeak [ 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
- Grey zone [ 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
- Heart rate [ Time Frame: From start of anesthesia to end of anesthesia ]Heart rate determined by electrocardiogram (beats/min)
- Pulse oximetry [ Time Frame: From start of anesthesia to end of anesthesia ]Pulse oximetry determined by photoplethysmography (%)
- End-tidal carbon dioxide [ Time Frame: From start of anesthesia to end of anesthesia ]End-tidal carbon dioxide measured from ventilatory circuit (mmHg)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963089
|Contact: Sang-Hwan Ji, M.D.||email@example.com|
|Contact: Young-Eun Jang, M.D.||firstname.lastname@example.org|
|Principal Investigator:||Jin-Tae Kim, M.D, Ph.D.||Seoul National University Hospital|