NCT06107257

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

Keywords

Cardiogenic Pulmonary EdemaAcute pulmonary edemaNon-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Survival Analysis

    6 months after cardiogenic acute pulmonary edema

Eligibility Criteria

Age76 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gériatrie - Service de Soins de Soins Médicaux et de Réadaptation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Related Publications (1)

  • Haddi L, Valerio L, Bilbault P, Kaltenbach G, Schmitt E. Effect of noninvasive ventilation on 6-month mortality in patients with acute cardiogenic pulmonary oedema: a retrospective study dedicated to older persons. Intern Emerg Med. 2025 Sep;20(6):1753-1760. doi: 10.1007/s11739-025-04012-3. Epub 2025 Jun 15.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Locations