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CompletedNCT01791530TAVeMUpdated Aug 6, 2015

International Multicenter Study of Ventilator Associated Tracheobronchitis.

An observational study in Incidence of VAT, sponsored by Corporacion Parc Tauli. Completed at 8 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-06.

Sponsored by Corporacion Parc Tauli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Incidence of VAT

Keywords

  • VAT
  • VAP
  • Transition from VAT to VAP
03

In context

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

10-20 consecutive admissions with a predictive duration of intubation and mechanical ventilation > 48h.

Inclusion criteria

  • 10-20 consecutive admissions with a predictive duration of intubation and mechanical ventilation > 48h.

Exclusion criteria

Exclusion Criteria:

  • Predicted duration of intubation and mechanical ventilation ≤ 48h.
  • Tracheostomy at ICU admission.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (actual)
Patient registry
No

Groups and cohorts

  • MV>48h

    10-20 consecutive admissions with a predictive duration of intubation and mechanical ventilation \> 48h.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. Secondary Objectives

    To determine risk factors for VAT.

    Time frame: 1 year

  2. To determine incidence and risk factors for transition from VAT to VAP.

    Time frame: 1 year

  3. To determine microorganisms associated with VAT.

    Time frame: 1 year

  4. To determine the impact of VAT on outcome.

    Time frame: 1 year

07

Study locations

8 sites
  • Argentina
    Argentina, Argentina
  • Bolivia
    Bolivia, Bolivia
  • Brazil
    Brazil, Brazil
  • Colombia
    Colombia, Colombia
  • Ecuador
    Ecuador, Ecuador
  • France
    France, France
  • Portugal
    'Portugal, Portugal
  • Corporació Sanitària I Universitaria Parc Taulí - Hospital de Sabadell
    Sabadell, Barcelona 08208, Spain
08

References and documents

Publications

  • 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. PubMed 31620836 ↗
  • 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. PubMed 26472037 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01791530
Lead sponsor
Corporacion Parc Tauli
Responsible party
Ignacio Martin-Loeches (MD PhD, Corporacion Parc Tauli) — Principal investigator
First posted
Feb 15, 2013
Start date
Sep 2013
Primary completion
Jul 2014
Completion
Sep 2014
Last update
Aug 6, 2015

Study contacts

Ignacio Martin-Loeches, MD PhD
principal investigator · CORPORACIÓ SANITÀRIA I UNIVERSITARIA PARC TAULÍ - HOSPITAL DE SABADELL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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