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

The Comparison of the 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.

Study Overview

• Status: Completed
• Conditions: PVI
• Intervention / Treatment: Device: pvi

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• Turkey
  • Maltepe
    • Istanbul, Maltepe, Turkey, 34854
      • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

pediatric patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PVI values; PVI values measured at the finger and forehead areas in pediatric patients	Device: pvi; 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.
no control group	Device: pvi; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output (CO)	Cardiac output (CO) values were recorded by noninvasive cardiac output monitoring	15 minute intervals during surgery

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: April 5, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 09.2020.132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes