RPVI for Fluid Responsiveness in Children

Not Applicable

Not yet recruiting

• Conditions: Anesthesia; Fluid Responsiveness
• Interventions: Procedure: Fluid loading; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: PVI, RPVI; Procedure: Tidal volume change

• Registration Number: NCT05601622
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-31
• Status Verified: 2022-11
• Study First Posted: 2022-11-01
• Last Update Submitted: 2022-11-13
• Study Start: 2022-11-15
• Last Update Posted: 2022-11-16
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Children undergoing neurosurgery under general anesthesia

Exclusion Criteria

• Presence of any cardiovascular disease
• Presence of any pulmonary disease
• Decline of enrollment from any of the patient's parents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	PVI, RPVI	Fluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation
Study group	Tidal volume change	Fluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation
Study group	Fluid loading	Fluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation
Study group	Transthoracic echocardiography	Fluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation

Primary Outcome Measures

Name	Time	Method
AUC of ROC curve	From start of anesthesia to end of anesthesia, Less than 24 hours	Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness

Secondary Outcome Measures

Name	Time	Method
SpO2	From start of anesthesia to end of study, Less than 24 hours	Pulse oximetry during the study for monitoring whether hypoxia appears.
Appearance of abnormal heart rhythm	From start of anesthesia to end of study, Less than 24 hours	Electrocardiogram during the study for monitoring whether tachycardia, bradycardia, or arrhythmia appears. Heart rate will be compared between patients who were fluid responsive and who were not responsive.
IBP	From start of anesthesia to end of study, Less than 24 hours	Invasive blood pressure during the study, including systolic, diastolic, mean blood pressure for monitoring whether hypertension or hypotension appears. Mean blood pressure will be compared between patients who were fluid responsive and who were not responsive.