NCT05601622

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

October 20, 2022

Last Update Submit

November 13, 2022

Conditions

AnesthesiaFluid Responsiveness

Keywords

Fluid responsivenesspleth variability index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • SpO2

    From start of anesthesia to end of study, Less than 24 hours

Study Arms (1)

Study group

EXPERIMENTAL

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 loadingDiagnostic Test: Transthoracic echocardiographyDiagnostic Test: PVI, RPVIProcedure: Tidal volume change

Interventions

Fluid loadingPROCEDURE

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

Study group
Transthoracic echocardiographyDIAGNOSTIC_TEST

Transthoracic echocardiographic measurement of stroke volume index

Study group
PVI, RPVIDIAGNOSTIC_TEST

Continuous measurement of pleth variability index and Rainbow pleth variability index

Study group
Tidal volume changePROCEDURE

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

Study group

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children undergoing neurosurgery under general anesthesia

You may not qualify if:

  • Presence of any cardiovascular disease
  • Presence of any pulmonary disease
  • Decline of enrollment from any of the patient's parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24257389BACKGROUND

  • 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.

    PMID: 14523168BACKGROUND

  • 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.

    PMID: 11794169BACKGROUND

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Hee-Soo Kim, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+82220723661taepoongshin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2022

First Posted

November 1, 2022

Study Start

November 15, 2022

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share