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Incidence of VATTAVeMNCT01791530

International Multicenter Study of Ventilator Associated Tracheobronchitis.

An observational study of Incidence of VAT, run by Corporacion Parc Tauli at 8 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Incidence of VAT
How many people
3,000 participants
Where
8 sitesin 8 countries
Study dates
Sep 2013to Sep 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

8 sites in 8 countries.

8 sites in 8 countries

Argentina1 site
  • Argentina

    Argentina

Other trials in Argentina

Bolivia1 site
  • Bolivia

    Bolivia

Other trials in Bolivia

Brazil1 site
  • Brazil

    Brazil

Other trials in Brazil

Colombia1 site
  • Colombia

    Colombia

Other trials in Colombia

Ecuador1 site
  • Ecuador

    Ecuador

Other trials in Ecuador

France1 site
  • France

    France

Other trials in France

Portugal1 site
  • Portugal

    Portugal

Other trials in Portugal

Spain1 site
  • Corporació Sanitària I Universitaria Parc Taulí - Hospital de Sabadell

    Sabadell, Barcelona, 08208

Other trials in Spain

About this study

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.

Keywords
VAT, VAP, Transition from VAT to VAP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01791530
Study groupRoleWhat they receive
MV>48h10-20 consecutive admissions with a predictive duration of intubation and mechanical ventilation > 48h.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (4)
  1. Secondary Objectives

    To determine risk factors for VAT.

    Measured: 1 year

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

    Measured: 1 year

  3. To determine microorganisms associated with VAT.

    Measured: 1 year

  4. To determine the impact of VAT on outcome.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01791530
Sponsor's protocol ID
TAVeM
Acronym
TAVeM
Status last verified
Aug 2015
First submitted
11 Feb 2013
Last updated
6 Aug 2015
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Incidence of VAT, run by Corporacion Parc Tauli at 8 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Argentina, Bolivia, Brazil, Colombia, Ecuador and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the incidence of VAT in patients requiring intubation and mechanical ventilation >48h. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01791530, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.

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