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Clinical Trials/NCT05601622
NCT05601622
Not yet recruiting
Not Applicable

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

Seoul National University Hospital0 sites45 target enrollmentNovember 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Seoul National University Hospital
Enrollment
45
Primary Endpoint
AUC of ROC curve
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
October 20, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

AUC of ROC curve

Time Frame: 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 Outcomes

  • SpO2(From start of anesthesia to end of study, Less than 24 hours)
  • Appearance of abnormal heart rhythm(From start of anesthesia to end of study, Less than 24 hours)
  • IBP(From start of anesthesia to end of study, Less than 24 hours)

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