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OpenTrials
Completed

NCT Number: NCT04835610

Effectiveness of Finger and Forehead Plethysmographic Variability Index Monitoring in Pediatric Patients

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.

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Key information

Conditions

PVI

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

About this study

he 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.

Fifty pediatric patients with obtained parental consent and ethics committee approval underwent elective minor surgery were included into the study. Basic monitoring, finger and forehead perfusion index (PI) and PVI monitoring were applied. Hemodynamic parameters, PI, PVI, cardiac output (CO) values were recorded. The 15% increase in CO with passive leg raise (PLR) maneuver was estimated as fluid responsiveness. Two groups were created: Group R (fluid responsive); Group NR (fluid nonresponsive). Mann-Whitney U, t, chi-square and ROC tests were used in statistical evaluation.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PVI

Device

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.

Primary outcomes

  1. The Plethysmographic Variability Index (PVI)

    Time frame: 15 minute intervals during surgery

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

Secondary outcomes

  1. Cardiac output (CO)

    Time frame: 15 minute intervals during surgery

    Cardiac output (CO) values were recorded by noninvasive cardiac output monitoring

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Comparison of the Effectiveness of Finger and Forehead Plethysmographic Variability Index Monitoring in Pediatric Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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