RPVI for Fluid Responsiveness in Children

Seoul National University

Status: Not yet enrolling

Conditions: Fluid Responsiveness; Anesthesia

Treatments: Procedure: Tidal volume change; Diagnostic Test: PVI, RPVI; Diagnostic Test: Transthoracic echocardiography; Procedure: Fluid loading

Study type: Interventional

Funder types: Other

Identifiers

NCT05601622

2209-123-1363

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Study group

Experimental group

Description:

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

Treatment:

Diagnostic Test: PVI, RPVI

Procedure: Tidal volume change

Diagnostic Test: Transthoracic echocardiography

Procedure: Fluid loading