Use of ΔIVC for Early Diagnosis of AHF in AECOPD

NCT ID: NCT05327374

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 401 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-01-31

Brief 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.

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.

Conditions

Acute Decompensated Heart Failure; COPD Exacerbation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

AHF-group

patients with AECOPD and acute heart failure

calculation of the inferior vena cava collapsibility index

Intervention Type: DIAGNOSTIC_TEST

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

calculation of the inferior vena cava collapsibility index

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouira Semir, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

CHU Fattouma Bourguiba

Monastir, , Tunisia

Emergency Departement

Monastir, , Tunisia

Emergency department of fattouma bourguiba university hospital

Monastir, , Tunisia

Countries

Tunisia

Other Identifiers

ΔIVC /AHF/ AECOPD

Identifier Type: -

Identifier Source: org_study_id