Use of ΔIVC for Early Diagnosis of AHF in AECOPD

Diagnosis of Acute Heart Failure in Chronic Obstructive Pulmonary Disease Exacerbation Using the Inferior Vena Cava Collapsibilty Index

Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

This association is frequently underestimated with regard to the difficulty of clinical diagnosis.

The investigators expect that the application of the inferior vena cava collapsibility index (ΔIVC)could be useful in this issue.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure; COPD Exacerbation
• Intervention / Treatment: Diagnostic test: calculation of the inferior vena cava collapsibility index

Detailed Description

Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swanganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the ΔIVC for the early identification of AHF in patients presenting to the ED with acute COPD exacerbation.

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • CHU Fattouma Bourguiba
  • Monastir, Tunisia, 5020
    • Emergency department of fattouma bourguiba university hospital
  • Monastir, Tunisia, 5000
    • Emergency Departement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with history of COPD admitted to the emergency departmet for AECOPD and stable hemodynamic status

Description

Inclusion Criteria:

• patient with history of COPD and admitted to the emergency departement for AECOPD

Exclusion Criteria:

• impossibility to give consent to participate in the study, non consent patients
• post traumatic dyspnea
• instable hemodynamic or neurological status

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AHF-group; patients with AECOPD and acute heart failure	Diagnostic test: calculation of the inferior vena cava collapsibility index; the ΔIVC was calculated by the emergency physician who was blinded from the patient's medical history using the formula ((IVCmax-IVCmin)/IVCmax) X100.A cutoff of 15% was used to define the presence(<15%) or absence(>15%) of heart failure
non AHF-group; patients with AECOPD without acute heart failure	Diagnostic test: calculation of the inferior vena cava collapsibility index; the ΔIVC was calculated by the emergency physician who was blinded from the patient's medical history using the formula ((IVCmax-IVCmin)/IVCmax) X100.A cutoff of 15% was used to define the presence(<15%) or absence(>15%) of heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the performance of ΔIVC in the diagnosis of acute heart failure	the accuracy of ΔIVC in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve	1 day

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Nouira Semir, Professor, University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; COPD; Acute Heart Failure; Inferior vena cava; Collapsibility index
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ΔIVC /AHF/ AECOPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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