RPVI for Fluid Responsiveness in Children

NCT ID: NCT05601622

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-10-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Anesthesia Fluid Responsiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Fluid loading

Intervention Type PROCEDURE

Intravenous administration of 10ml/kg of crystalloids over 10 minutes

Transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiographic measurement of stroke volume index

PVI, RPVI

Intervention Type DIAGNOSTIC_TEST

Continuous measurement of pleth variability index and Rainbow pleth variability index

Tidal volume change

Intervention Type PROCEDURE

Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg

Interventions

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Fluid loading

Intravenous administration of 10ml/kg of crystalloids over 10 minutes

Intervention Type PROCEDURE

Transthoracic echocardiography

Transthoracic echocardiographic measurement of stroke volume index

Intervention Type DIAGNOSTIC_TEST

PVI, RPVI

Continuous measurement of pleth variability index and Rainbow pleth variability index

Intervention Type DIAGNOSTIC_TEST

Tidal volume change

Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Soo Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

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Sang-Hwan Ji, M.D., Ph.D.

Role: CONTACT

+82220723661

References

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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.

Reference Type BACKGROUND
PMID: 24257389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14523168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11794169 (View on PubMed)

Other Identifiers

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2209-123-1363

Identifier Type: -

Identifier Source: org_study_id

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