Clincosm LogoSign in Get a demo

CAPE: Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06107257
Collaborator
(none)
200
Enrollment
1
Location
10.9
Anticipated Duration (Months)
18.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

People aged over 75 represent almost 10% of the general population, and 12 to 14% of patients consulting emergency departments. Cardiogenic acute pulmonary edema (APO) is a very common reason for admission to the emergency room. The effectiveness of non-invasive ventilation (NIV) has been demonstrated during the management of PAO and would allow, compared to medical treatment alone, a more rapid improvement in clinical and gasometric parameters as well as a reduction in the need for ventilation. orotracheal intubation. On the other hand, the impact of NIV on mortality in cardiogenic PAO seems poorly defined, with lower levels of scientific evidence regarding a possible benefit in terms of survival, particularly in the elderly population.

The objective of this study is to determine whether the use of NIV in cardiogenic PAO in elderly subjects admitted to the emergency room of Strasbourg University Hospital would have an impact in terms of mortality up to 6 months compared to medical treatment alone.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Cardiogenic Acute Pulmonary Edema in Subjects Over 75 Years Old: Impact of Non-invasive Ventilation on Mortality
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Survival Analysis [6 months after cardiogenic acute pulmonary edema]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    76 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Adult subject (> 75 years old)

    • Admission to the NHC emergency room between January 1, 2021 and October 31, 2021

    • Diagnosis of cardiogenic PAO

    • Indication of NIV according to current recommendations

    • Subject not opposing the reuse of their data for scientific research purposes.

    Exclusion Criteria:

    • Subject having expressed his opposition to the reuse of his data for scientific research purposes.

    • Presence of an absolute contraindication to NIV

    • Respiratory distress due to pneumonia or other diagnosis

    • RT-PCR Sars Cov 2 positive in emergency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06107257
    Other Study ID Numbers:
    • 8785
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Cardiogenic Pulmonary Edema
    Acute pulmonary edema
    Non-invasive ventilation
    Additional relevant MeSH terms:
    Pulmonary Edema
    Edema

    Study Results

    No Results Posted as of Oct 30, 2023