RPVI for Fluid Responsiveness in Children

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Fluid Responsiveness
• Intervention / Treatment: Procedure: Fluid loading; Diagnostic test: Transthoracic echocardiography; Diagnostic test: PVI, RPVI; Procedure: Tidal volume change

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang-Hwan Ji, M.D., Ph.D.; Phone Number: +82220723661; Email: taepoongshin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study group; 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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appearance of abnormal heart rhythm	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.	From start of anesthesia to end of study, Less than 24 hours
IBP	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.	From start of anesthesia to end of study, Less than 24 hours
SpO2	Pulse oximetry during the study for monitoring whether hypoxia appears.	From start of anesthesia to end of study, Less than 24 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.
• Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e.
• Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. doi: 10.1542/peds.112.4.793.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2022
• Primary Completion (Anticipated): October 20, 2024
• Study Completion (Anticipated): October 20, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Fluid responsiveness; pleth variability index
• Other Study ID Numbers: 2209-123-1363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No