Pleth Variability Index in Pulmonary Embolism

Pulmonary embolism(PE) is a ventilation/perfusion disorder caused by obstruction of the pulmonary artery, usually by a thrombus. The Pleth Variability Index(PVI) 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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–93 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suleyman Demirel University Faculty of Medicine

Isparta, 32260, Turkey (Türkiye)

About this study

Pulmonary embolism(PE) is a ventilation/perfusion disorder caused by obstruction of the pulmonary artery, usually by a thrombus. The Pleth Variability Index(PVI) is a continuous, noninvasive indicator of dynamic perfusion index(PI) 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 (p=0.027, p=0.011). The area under the curve values for PVI, pulmonary embolism severity index (PESI) score, and PI were determined to be 0.714, 0.820, and 0.745, respectively. It was observed that the negative predictive value of PESI was 100%, while the positive predictive value of PVI was the highest at 53.5%. In the. The mean survival time was significantly shorter for patients with PVI >40 and PI <1.9 (p=0.001, p=0.002). An increase in PVI was associated with a 4.04-fold increase in the risk of death (HR: 5.04, 95% CI: 1.50-16.92, p=0.009).

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

To be over 18 years old
Diagnosis of pulmonary embolism

Exclusion criteria

patients had asthma and chronic obstructive pulmonary disease exacerbation
patients had acute decompensated heart failure
patients were pregnant
patient was under 18 years old

Treatment and study plan

Masimo Radical-7® Pulse CO-Oximeter

Device

Masimo Radical-7® Pulse CO-Oximeter device was attached to the index finger of the patients in the supine position and photoplethysmographic perfusion index and plethysmographic variability index were measured noninvasively, rapidly and continuously.

Primary outcomes

Pleth Variability Index: A Potential New Marker for Predicting the Mortality of Pulmonary Embolism?

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

Pleth Variability Index: A Potential New Marker for Predicting the Mortality of Pulmonary Embolism?

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 18, 2024
Registry last updated: Jul 18, 2024

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

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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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Completed