NCT06466980

Brief Summary

The aim is to describe the incidence, characteristics, risk factors and outcome of complications acquired under mechanical ventilation (called ventilator-associated events) according to the new CDC criteria, in a population of patients admitted in intensive care unit after cardiac arrest.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

June 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

June 27, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

June 14, 2024

Last Update Submit

March 12, 2025

Conditions

Keywords

Ventilator associated eventcardiac arrestventilator-acquired pneumoniaventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • number

    Incidence of ventilator associated event

    at day 28

Secondary Outcomes (4)

  • Associated factors

    at day 28

  • number of pneumonias

    at day 28

  • time

    at day 28

  • number of deaths

    at day 28

Interventions

Measure of incidence of Ventilator associated event

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted to intensive care unit after cardiac arrest at the South Francilien Hospital Center from January 2019 to December 2023

You may qualify if:

  • Adult male or female
  • Non-pregnant female
  • Successfully resuscitated from cardiac arrest during primary care
  • Invasive mechanical ventilation initiated during resuscitation and continued for at least 4 days
  • No decision to limit life-sustaining therapies within 24 hours following admission to intensive care
  • No requirement of arteriovenous circulatory support during intensive care management

You may not qualify if:

  • \- patients who opposed to the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

RECRUITING

Related Publications (2)

  • American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.

    PMID: 15699079BACKGROUND
  • Perbet S, Mongardon N, Dumas F, Bruel C, Lemiale V, Mourvillier B, Carli P, Varenne O, Mira JP, Wolff M, Cariou A. Early-onset pneumonia after cardiac arrest: characteristics, risk factors and influence on prognosis. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1048-54. doi: 10.1164/rccm.201102-0331OC.

    PMID: 21816940BACKGROUND

MeSH Terms

Conditions

Heart ArrestPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHealthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

June 27, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations