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

PVI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835610
• Other study ID #: 09.2020.132
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: April 27, 2020

Study information

• Verified date: June 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 27, 2020
• Est. primary completion date: April 2, 2020
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• PVI

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac output (CO)	Cardiac output (CO) values were recorded by noninvasive cardiac output monitoring	15 minute intervals during surgery