Clinical trial NCT01791530: International Multicenter Study of Ventilator Associated Tracheobronchitis.
Official title: International Multicenter Study of Ventilator Associated Tracheobronchitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of VAT
Keywords: VAT
VAP
Transition from VAT to VAP
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10-20 consecutive admissions with a predictive duration of intubation and mechanical ventilation \> 48h.

Brief summary: 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

Detailed description: METHODS This prospective international multicentre observational study will be conducted in 8 countries ((Spain, France, Portugal, Brazil, Argentina, Ecuador, Bolivia and Colombia).) 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. Primary objective To determine the incidence of VAT in patients requiring intubation and mechanical ventilation \>48h.

Secondary objectives To determine risk factors for VAT. To determine incidence and risk factors for transition from VAT to VAP. To determine microorganisms associated with VAT. To determine the impact of VAT on outcome.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the incidence of VAT in patients requiring intubation and mechanical ventilation >48h.
timeFrame: 1 year
Secondary outcomes:
measure: Secondary Objectives
timeFrame: 1 year
measure: To determine incidence and risk factors for transition from VAT to VAP.
timeFrame: 1 year
measure: To determine microorganisms associated with VAT.
timeFrame: 1 year
measure: To determine the impact of VAT on outcome.
timeFrame: 1 year
Other outcomes:
Locations:
city: Argentina
country: Argentina
facility: Argentina
city: Bolivia
country: Bolivia
facility: Bolivia
city: Brazil
country: Brazil
facility: Brazil
city: Colombia
country: Colombia
facility: Colombia
city: Ecuador
country: Ecuador
facility: Ecuador
city: France
country: France
facility: France
city: 'Portugal
country: Portugal
facility: Portugal
city: Sabadell
country: Spain
facility: Corporació Sanitària I Universitaria Parc Taulí - Hospital de Sabadell
state: Barcelona
Study officials:
affiliation: CORPORACIÓ SANITÀRIA I UNIVERSITARIA PARC TAULÍ - HOSPITAL DE SABADELL
name: Ignacio Martin-Loeches, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin-Loeches I, Torres A, Povoa P, Zampieri FG, Salluh J, Nseir S, Ferrer M, Rodriguez A; TAVeM study Group. The association of cardiovascular failure with treatment for ventilator-associated lower respiratory tract infection. Intensive Care Med. 2019 Dec;45(12):1753-1762. doi: 10.1007/s00134-019-05797-6. Epub 2019 Oct 16.
citation: Martin-Loeches I, Povoa P, Rodriguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.