Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06107257
Other study ID # 8785
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source University Hospital, Strasbourg, France
Contact Elise SCHMITT, MD
Phone 33 3 88 11 58 84
Email elise.schmitt@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2023
Est. primary completion date December 2023
Accepts healthy volunteers
Gender All
Age group 76 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Analysis 6 months after cardiogenic acute pulmonary edema
See also
  Status Clinical Trial Phase
Completed NCT04971213 - HIgh Flow Versus NIV for Acute Cardiogenic PuLmonary Oedema With Acute Respiratory Failure in an ED N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A
Completed NCT00785174 - Non-Invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema: a Multicentre Study Phase 3
Completed NCT04005092 - Helmet CPAP Versus HFNC in Acute Cardiogenic Pulmonary Edema N/A
Completed NCT03041428 - Ultra Protective Ventilation During Venoarterial Extracorporeal Membrane Oxygenation (UPV-ECMO) N/A
Completed NCT00390442 - Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema Phase 3