Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-01 @ 1:46 PM
Study NCT ID:
NCT06508112
Status:
COMPLETED
Last Update Posted:
2024-07-18
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pleth Variability Index in Pulmonary Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2024-07-12', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pleth Variability Index: A Potential New Marker for Predicting the Mortality of Pulmonary Embolism?', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary embolism', 'Perfusion Index', 'Plethysmography', 'mortality'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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.', 'detailedDescription': '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.\n\nIn 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.\n\nA 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).\n\nPVI 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '93 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be over 18 years old\n* Diagnosis of pulmonary embolism\n\nExclusion Criteria:\n\n* patients had asthma and chronic obstructive pulmonary disease exacerbation\n* patients had acute decompensated heart failure\n* patients were pregnant\n* patient was under 18 years old'}, 'identificationModule': {'nctId': 'NCT06508112', 'briefTitle': 'Pleth Variability Index in Pulmonary Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Suleyman Demirel University'}, 'officialTitle': 'Pleth Variability Index: A Potential New Marker for Predicting the Mortality of Pulmonary Embolism?', 'orgStudyIdInfo': {'id': 'SuleymanDU-MED-TEŞ-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients diagnosed pulmonary embolism', 'description': '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.', 'interventionNames': ['Device: Masimo Radical-7® Pulse CO-Oximeter']}], 'interventions': [{'name': 'Masimo Radical-7® Pulse CO-Oximeter', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['patients diagnosed pulmonary embolism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32260', 'city': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Suleyman Demirel University Faculty of Medicine', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}], 'overallOfficials': [{'name': 'Teslime Eryavuz Şengül, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'suleyman demirel university faculty of medicine'}, {'name': 'Hamit H Armağan, assoc prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'suleyman demirel university faculty of medicine'}, {'name': 'Furkan Ç Oğuzlar, asst prof', 'role': 'STUDY_CHAIR', 'affiliation': 'suleyman demirel university faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suleyman Demirel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Teslime Eryavuz Şengül', 'investigatorAffiliation': 'Suleyman Demirel University'}}}}