Ventilator - Associated Event After Cardiac Arrest

Mechanical Ventilation Clinical Trial

— VAE-ACR  

Official title:

Ventilator - Associated Event After Cardiac Arrest : a Retrospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466980
• Other study ID #: 2024/0009
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Sud Francilien
• Contact: Fabrice COOK, MD
• Phone: 01 61 69 52 28
• Email: fabrice.cook[@]chsf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 [8]. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest With Successful Resuscitation
• Heart Arrest
• Mechanical Ventilation

Intervention

Other:
• Ventilator associated event
Measure of incidence of Ventilator associated event

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number	Incidence of ventilator associated event	at day 28
Secondary	Associated factors	Associated factors of ventilator associated event	at day 28
Secondary	number of pneumonias	Ventilator associated pneumonia according to the American Thoracic Society definition	at day 28
Secondary	time	Mechanical ventilation duration	at day 28
Secondary	number of deaths	In-hospital mortality	at day 28