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

Recruiting

• Conditions: Cardiac Arrest With Successful Resuscitation; Mechanical Ventilation

• Registration Number: NCT06466980
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-20
• Study Start: 2024-06-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number	at day 28	Incidence of ventilator associated event

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France