Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508112
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Pleth Variability Index in Pulmonary Embolism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pleth Variability Index A Potential New Marker for Predicting the Mortality of Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary embolismPE is a ventilationperfusion disorder caused by obstruction of the pulmonary artery usually by a thrombus The Pleth Variability IndexPVI is a continuous noninvasive indicator of dynamic perfusion index changes in photoplethysmography that occur in at least one respiratory cycle The aim of this study is to evaluate the prognostic and mortality indicator role of PVI in patients with PE hypothesizing that PVI could serve as a valuable guide in this disease where perfusion impairment is fundamental
Based on our study we determined that PVI could be a non-invasive rapid and objective tool for predicting disease progression and mortality in PE patients in the emergency department Our study is the first to evaluate the PVI in PE
Based on our study we determined that PVI could be a non-invasive rapid and objective tool for predicting disease progression and mortality in PE patients in the emergency department Our study is the first to evaluate the PVI in PE
Detailed Description:
Pulmonary embolismPE is a ventilationperfusion disorder caused by obstruction of the pulmonary artery usually by a thrombus The Pleth Variability IndexPVI is a continuous noninvasive indicator of dynamic perfusion indexPI changes in photoplethysmography that occur in at least one respiratory cycle The aim of this study is to evaluate the prognostic and mortality indicator role of PVI in patients with PE hypothesizing that PVI could serve as a valuable guide in this disease where perfusion impairment is fundamental
In the emergency department data were recorded for patients over 18 years of age diagnosed with pulmonary embolism demographic data risk scores and measurements PVI and PI values were analyzed across different scoring systems hospitalization statuses and mortality groups A survival analysis was conducted to evaluate the impact of PVI and PI on 1-year mortality in patients The study was assessed with the STROBE checklist
A total of 49 patients were included in this prospective single-center study The PVI value was significantly higher whereas the PI value was significantly lower in the exitus group compared to the living group p0027 p0011 The area under the curve values for PVI pulmonary embolism severity index PESI score and PI were determined to be 0714 0820 and 0745 respectively It was observed that the negative predictive value of PESI was 100 while the positive predictive value of PVI was the highest at 535 In the The mean survival time was significantly shorter for patients with PVI 40 and PI 19 p0001 p0002 An increase in PVI was associated with a 404-fold increase in the risk of death HR 504 95 CI 150-1692 p0009
PVI can be considered a noninvasive rapid and objective tool for predicting the course and mortality of the disease in PE patients in the emergency department Our study is the first to evaluate the PVI in PE
In the emergency department data were recorded for patients over 18 years of age diagnosed with pulmonary embolism demographic data risk scores and measurements PVI and PI values were analyzed across different scoring systems hospitalization statuses and mortality groups A survival analysis was conducted to evaluate the impact of PVI and PI on 1-year mortality in patients The study was assessed with the STROBE checklist
A total of 49 patients were included in this prospective single-center study The PVI value was significantly higher whereas the PI value was significantly lower in the exitus group compared to the living group p0027 p0011 The area under the curve values for PVI pulmonary embolism severity index PESI score and PI were determined to be 0714 0820 and 0745 respectively It was observed that the negative predictive value of PESI was 100 while the positive predictive value of PVI was the highest at 535 In the The mean survival time was significantly shorter for patients with PVI 40 and PI 19 p0001 p0002 An increase in PVI was associated with a 404-fold increase in the risk of death HR 504 95 CI 150-1692 p0009
PVI can be considered a noninvasive rapid and objective tool for predicting the course and mortality of the disease in PE patients in the emergency department Our study is the first to evaluate the PVI in PE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None