NCT04835610

Brief Summary

In pediatric surgical patients, the sensitivity of forehead and finger PVI monitoring was similar for the prediction of fluid responsiveness, whereas the specificity of forehead monitoring was higher. The use of forehead PVI probes in the fluid management of these patients seemed to be appropriate because cephalic region was not affected by low perfusion states.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

April 5, 2021

Last Update Submit

June 16, 2021

Conditions

PVI

Outcome Measures

Primary Outcomes (1)

  • The Plethysmographic Variability Index (PVI)

    The Plethysmographic Variability Index (PVI) can be measured with both finger and forehead probes by pvi monitoring.

    15 minute intervals during surgery

Secondary Outcomes (1)

  • Cardiac output (CO)

    15 minute intervals during surgery

Study Arms (2)

PVI values

PVI values measured at the finger and forehead areas in pediatric patients

Device: pvi

no control group

no control group

Device: pvi

Interventions

pviDEVICE

The Plethysmographic Variability Index (PVI) can be measured with both finger and forehead probes. Vasoconstriction may reduce the reliability of PVI measurements in pediatric surgical patients prone to hypothermia. The vascular structure of the forehead area is resistant to changes in vasomotor tonus. The aim of our study is to compare the efficacy of PVI values measured at the finger and forehead areas to predict fluid responsiveness in these patients.

PVI valuesno control group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pediatric patients

You may qualify if:

  • written consent from their parents patients undergoing elective minor surgery with bleeding less than 500ml Children between the ages of 5-12.

You may not qualify if:

  • those who stay in the specified age range those with cardiopulmonary disease spontaneous breathing positive allen test peripheral circulatory failure vasopressor therapy anemia hypothermic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

Study Officials

  • MELIHA ORHON ERGUN

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 8, 2021

Study Start

January 20, 2020

Primary Completion

April 2, 2020

Study Completion

April 27, 2020

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

TU(1)