Clinical trial NCT06466980: Study of Ventilator Associated Event During Intensive Care After Resuscitated Cardiac Arrest.
Official title: Study of Ventilator Associated Event During Intensive Care After Resuscitated Cardiac Arrest.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest With Successful Resuscitation
Mechanical Ventilation
Keywords: Ventilator associated event
cardiac arrest
ventilator-acquired pneumonia
ventilator associated pneumonia
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: number
timeFrame: at day 28
Secondary outcomes:
measure: Associated factors
timeFrame: at day 28
measure: number of pneumonias
timeFrame: at day 28
measure: time
timeFrame: at day 28
measure: number of deaths
timeFrame: at day 28
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
citation: 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.
citation: 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.