Study of Ventilator Associated Event During Intensive Care After Resuscitated Cardiac Arrest. (VAE-ACR)

March 12, 2025 updated by: Centre Hospitalier Sud Francilien
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiac arrest (CA) survivors are frequently admitted to intensive care units. Despite improvements in management techniques, the prognosis of these patients remains poor, with mortality exceeding 90% for out-of-hospital CA and around 80% for in-hospital CA, along with a high risk of severe neurological issue.

The management of these patients in intensive care requires the use of invasive mechanical ventilation. Complications occurring under mechanical ventilation have been the subject of many researches. Early bacterial pneumonia or ventilator-acquired pneumonia appears as the primary cause of respiratory worsening, and several studies have already focused on their incidence and prevention. However, studies on the benefits of antibiotic therapy or antibiotic prophylaxis for early pulmonary infections are of tricky analysis, particularly when they do not consider respiratory condition or mortality for their primary outcome measure.

A new definition of complications associated with mechanical ventilation (VAEs) has been established by the Centers for Disease Control and Prevention (CDC) since 2013. It offers a more relevant tool for monitoring the impact of preventive measures on morbidity and mortality, with a more objective definition that goes beyond just tracking ventilator-associated pneumonia.

Several studies have since analyzed the incidence and impact of VAEs on cohorts of intensive care patients, confirming the association between VAEs and morbidity and mortality. However, to our knowledge, none have targeted a population of cardiac arrest survivors.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Corbeil-essonnes Cedex, France, 91106
        • Recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
        • Contact:
          • Fabrice COOK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria

- patients who opposed to the use of their data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number
Time Frame: at day 28
Incidence of ventilator associated event
at day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associated factors
Time Frame: at day 28
Associated factors of ventilator associated event
at day 28
number of pneumonias
Time Frame: at day 28
Ventilator associated pneumonia according to the American Thoracic Society definition
at day 28
time
Time Frame: at day 28
Mechanical ventilation duration
at day 28
number of deaths
Time Frame: at day 28
In-hospital mortality
at day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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