Use of ΔIVC for Early Diagnosis of AHF in AECOPD

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327374
• Other study ID #: ?IVC /AHF/ AECOPD
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: May 2023
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: January 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• COPD Exacerbation
• Heart Failure

Intervention

Diagnostic Test:
• calculation of the inferior vena cava collapsibility index
the ?IVC 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

Locations

Country	Name	City	State
Tunisia	CHU Fattouma Bourguiba	Monastir
Tunisia	Emergency Departement	Monastir
Tunisia	Emergency department of fattouma bourguiba university hospital	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the performance of ?IVC in the diagnosis of acute heart failure	the accuracy of ?IVC in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve	1 day