NCT03963089

Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Plasma Volume
• Tidal Volume

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-30
• Primary completion: 2020-06-23
• Completion: 2020-10-06
• First posted: 2019-05-24
• Last updated: 2022-05-05

Locations

1 site across 1 country: South Korea