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NCT Number: NCT06466980

Study of Ventilator Associated Event During Intensive Care After Resuscitated Cardiac Arrest.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location status: Recruiting

Location contact

Caroline TOURTE

CONTACT

[email protected]

0161693730

Fabrice COOK

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventilator associated event

Other

Measure of incidence of Ventilator associated event

Primary outcomes

  1. number

    Time frame: at day 28

    Incidence of ventilator associated event

Secondary outcomes

  1. Associated factors

    Time frame: at day 28

    Associated factors of ventilator associated event

  2. number of pneumonias

    Time frame: at day 28

    Ventilator associated pneumonia according to the American Thoracic Society definition

  3. time

    Time frame: at day 28

    Mechanical ventilation duration

  4. number of deaths

    Time frame: at day 28

    In-hospital mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline TOURTE

CONTACT

[email protected]

01 61 69 31 50

Fabrice COOK, MD

CONTACT

[email protected]

01 61 69 52 28

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: VAE-ACR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 20, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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