Pleth Variability Index in Pulmonary Embolism

NCT06508112 | Completed

• 1 other identifier: SuleymanDU-MED-TEŞ-01
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; Perfusion Index; Plethysmography; mortality

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

patients diagnosed pulmonary embolism

Eligibility Criteria

• Age: 18 Years - 93 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• To be over 18 years old
• Diagnosis of pulmonary embolism

You may not qualify if:

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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University Faculty of Medicine

Isparta, 32260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

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

Study Officials

• Teslime Eryavuz Şengül, M.D.

  suleyman demirel university faculty of medicine

  PRINCIPAL INVESTIGATOR

• Hamit H Armağan, assoc prof

  suleyman demirel university faculty of medicine

  STUDY DIRECTOR

• Furkan Ç Oğuzlar, asst prof

  suleyman demirel university faculty of medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: June 1, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)