NCT05601622

RPVI for Fluid Responsiveness in Children

Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.

Detailed description

Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg. To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI. According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.

Conditions

• Anesthesia
• Fluid Responsiveness

Interventions

Type	Name	Description
PROCEDURE	Fluid loading	Intravenous administration of 10ml/kg of crystalloids over 10 minutes
DIAGNOSTIC_TEST	Transthoracic echocardiography	Transthoracic echocardiographic measurement of stroke volume index
DIAGNOSTIC_TEST	PVI, RPVI	Continuous measurement of pleth variability index and Rainbow pleth variability index
PROCEDURE	Tidal volume change	Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-10-20
• Completion: 2024-10-20
• First posted: 2022-11-01
• Last updated: 2022-11-16