Pleth Variability Index in Pulmonary Embolism

Pleth Variability Index: A Potential New Marker for Predicting the Mortality of 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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Masimo Radical-7® Pulse CO-Oximeter

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32260
    • suleyman demirel university faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18 who presented to the emergency department of a tertiary care hospital between April 1, 2023, and March 31, 2024, with complaints of cough, dyspnea, chest pain, tachycardia, hemoptysis, and syncope, and were diagnosed with PE confirmed by pulmonary computed tomographic angiography (CTPA), were included in our study. Informed consent was obtained from the patients who were stable and from the relatives of the patients who were unstable.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients diagnosed pulmonary embolism; Patients over the age of 18 who presented to the emergency department of a tertiary care hospital with complaints of cough, dyspnea, chest pain, tachycardia, hemoptysis, and syncope, and were diagnosed with pulmonary embolism (PE) confirmed by pulmonary computed tomographic angiography (CTPA), were included in our study. Informed consent was obtained from the patients who were stable and from the relatives of the patients who were unstable. Plethysmographic variability index (PVI) and Perfusion index (PI) levels were automatically obtained 2 minutes after the device was attached, using a probe placed on the index finger of the hand while the patient was lying supine. PI and PVI measurements and data were collected consecutively by the same individual. The measurements were taken using the Masimo Radical-7® Pulse CO-Oximeter, which is approved by the U.S. Food and Drug Administration.

Device: Masimo Radical-7® Pulse CO-Oximeter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pleth Variability Index: A Potential New Marker for Predicting the Mortality of Pulmonary Embolism?	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.	1 year

Collaborators and Investigators

• Sponsor: Suleyman Demirel University
• Investigators: Principal Investigator: Teslime Eryavuz Şengül, M.D., suleyman demirel university faculty of medicine; Study Director: Hamit H Armağan, assoc prof, suleyman demirel university faculty of medicine; Study Chair: Furkan Ç Oğuzlar, asst prof, suleyman demirel university faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: mortality; pulmonary embolism; Plethysmography; Perfusion Index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: SuleymanDU-MED-TEŞ-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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