Clinical trial NCT05601622: RPVI for Fluid Responsiveness in Children
Official title: Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Fluid Responsiveness
Keywords: Fluid responsiveness
pleth variability index
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 45
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUC of ROC curve
timeFrame: From start of anesthesia to end of anesthesia, Less than 24 hours
Secondary outcomes:
measure: Appearance of abnormal heart rhythm
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: IBP
timeFrame: From start of anesthesia to end of study, Less than 24 hours
measure: SpO2
timeFrame: From start of anesthesia to end of study, Less than 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.