Incidence of VAT Clinical Trial
— TAVeMOfficial title:
International Multicenter Study of Ventilator Associated Tracheobronchitis.
| Verified date | August 2015 |
| Source | Corporacion Parc Tauli |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: IRB Parc Tauli |
| Study type | Observational |
Justification and background Ventilator-associated complications (VACs) are those
complications that develop during a period of intubation of a patient . Pneumonia is the
second most frequent infectious complication in the hospital, and ranks first in ICU, whose
risk is increased more than 20 times by the presence of invasive mechanical ventilation and
is called ventilator-associated pneumonia (VAP) . Whereas the information published
regarding VAP in terms of diagnosis, treatment and impact on the outcome of critically ill
patients is enormous.Ventilator-associated tracheobronchitis (VAT) incidence is lacking and
complicated in part, since the definition remains controversial. In addition, the
significance of tracheobronchial colonization as a risk factor for subsequent lower
respiratory tract infection remains unclear . The upper and lower airways can become
colonized . Several factors have been taken into account and do not differ from those
involved in VAT and VAP development in patients under mechanical ventilation.
Definition VAT diagnosis is controversial and represents an actual problem in order to
define the real incidence of VAT , There is currently no valid, reliable definition for VAT,
and even the most widely-used VAT criteria and definitions are neither sensitive nor
specific. The diagnosis of VAT is considered when a patient under invasive mechanical
ventilation starts with fever, leukocytosis and new or increased purulent secretions by the
endotracheal tube. A particular difficulty with much commonly used VAT definition (in order
to distinguish from VAP) is the key point of the absence of pulmonary consolidation.
Evidence suggests that chest radiograph findings do not accurately role out VAP. A taskforce
on hospital-acquired pneumonia, and VAP has been recently published (European Respiratory
Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID)
and European Society of Intensive Care Medicine (ESICM)). Nosocomial tracheobronchitis
definition includes occurrence of purulent tracheal secretion after ≥48 h of hospitalisation
or mechanical ventilation plus ≥2 of the following: fever (≥38.5°C) or hypothermia (<36°C),
leukocytosis (≥12 × 109/L), significant bacteriologic counts in respiratory secretions (≥103
cfu/mL for protected brush specimen (PBS) and ≥105 cfu/mL for endotracheal aspirates);
absence of new pulmonary infiltrates compatible with pneumonia and absence of other causes
of fever are mandatory. This definition needs to be further validated and can overdiagnose
the incidence of VAT (and overuse of antibiotics) because the positive culture of
respiratory secretions is not a mandatory item RATIONALE Given the possible high incidence
of VAT, and its importance as a risk factor for VAP, and a potential target to treat in
order to reduce VAP incidence, a large multicentre
| Status | Completed |
| Enrollment | 3000 |
| Est. completion date | September 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 10-20 consecutive admissions with a predictive duration of intubation and mechanical ventilation > 48h. Exclusion Criteria: - Predicted duration of intubation and mechanical ventilation = 48h. - Tracheostomy at ICU admission. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Argentina | Argentina | |
| Bolivia | Bolivia | Bolivia | |
| Brazil | Brazil | Brazil | |
| Colombia | Colombia | Colombia | |
| Ecuador | Ecuador | Ecuador | |
| France | France | France | |
| Portugal | Portugal | `Portugal | |
| Spain | Corporació Sanitària I Universitaria Parc Taulí - Hospital de Sabadell | Sabadell | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Corporacion Parc Tauli |
Argentina, Bolivia, Brazil, Colombia, Ecuador, France, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the incidence of VAT in patients requiring intubation and mechanical ventilation >48h. | To determine the incidence of VAT in patients requiring intubation and mechanical ventilation >48h. | 1 year | No |
| Secondary | Secondary Objectives | To determine risk factors for VAT. | 1 year | No |
| Secondary | To determine incidence and risk factors for transition from VAT to VAP. | 1 year | No | |
| Secondary | To determine microorganisms associated with VAT. | 1 year | No | |
| Secondary | To determine the impact of VAT on outcome. | 1 year | No |