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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Pulmonary Edema

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Elise SCHMITT, MD; Phone Number: 33 3 88 11 58 84; Email: elise.schmitt@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France
    • Contact: Elise SCHMITT, MD; Phone Number: 33 3 88 11 58 84; Email: elise.schmitt@chru-strasbourg.fr
    • Principal Investigator: Elise SCHMITT, MD
    • Contact: Linda HADDI, MD; Phone Number: 33 3 88 11 58 84; Email: linda.haddi@chru-strasbourg.fr
    • Principal Investigator: Linda HADDI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult subject (> 75 years) with a diagnosis of cardiogenic PAO treated at Strasbourg University Hospital between January 1, 2021 and October 31, 2021

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival Analysis	6 months after cardiogenic acute pulmonary edema

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Cardiogenic Pulmonary Edema; Acute pulmonary edema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: 8785 (DUMC old IRB number)

Drug and device information, study documents

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