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

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04835610
Collaborator
(none)
2
1
3.2
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
2 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Comparison of the Effectiveness of Finger and Forehead Plethysmographic Variability Index Monitoring in Pediatric Patients
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Apr 2, 2020
Actual Study Completion Date :
Apr 27, 2020

Arms and Interventions

Arm 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

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.

Outcome Measures

Primary Outcome Measures

  1. The Plethysmographic Variability Index (PVI) [15 minute intervals during surgery]

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

Secondary Outcome Measures

  1. Cardiac output (CO) [15 minute intervals during surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Istanbul Maltepe Turkey 34854

Sponsors and Collaborators

  • Marmara University

Investigators

  • Principal Investigator: MELIHA ORHON ERGUN, Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meliha Orhon, assistant professor, Marmara University
ClinicalTrials.gov Identifier:
NCT04835610
Other Study ID Numbers:
  • 09.2020.132
First Posted:
Apr 8, 2021
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Jun 18, 2021