Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03129893 |
Other study ID # |
PICU-BG-TT |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2017 |
Est. completion date |
June 30, 2019 |
Study information
Verified date |
August 2023 |
Source |
Fondazione per la Ricerca Ospedale Maggiore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The CDC definition was used to identify patients with VAP and VAT. The CDC definition of VAP
for infants < 1 y.o. and children > 1 or < 12 y.o. are based on clinical and X-ray criteria.
The CDC definition of Tracheitis are based on absence of clinical and radiographic evidence
of pneumonia and the following criteria: positive culture obtained by deep tracheal aspirate
and 2 signs of symptoms with no recognizable cause [such as fever (>38.5°C), cough, new or
increased sputum production, rhonchi, or wheezing].
The new CDC definition is used to identify patients with VAC and IVAC. The new definitions
includes all associated complications (infection included) related to mechanical ventilation
and exclude X-ray criteria.
VAP, VAT, VAC, IVAC rate, expressed as the number of VAP/VAT/VAC/IVAC episodes per 1000
mechanical ventilator days (VAP/1000 MV days), were calculated for phase 1 and phase 2.
Description:
Ventilator associated pneumoniae (VAP) occurs in 9-27% of all intubated patients and is
associated to an important morbidity and mortality. It is a serious complication among
neonates and pediatric patients after cardiac surgery accounting for 6.8-32.2% of health-care
associated infections. Ventilator associated tracheobronchitis (VAT) is common in adults and
it has been described as a risk factor for the development of VAP. Studies have shown that
treatment of VAT is associated with a lower rate of VAP and a lower mortality in adult
patients. VAT has also been described in premature infants and children but it has been less
studied than in adults.Recently, the Centers for Disease Control and Prevention (CDC) rolled
out new surveillance definitions for patients receiving mechanical ventilation to be more
objective and to render the data easier to collect and verify. The terms include
ventilator-associated condition (VAC) and infection-related, ventilator-associated
complication (IVAC). Studies in adults demonstrated that the VAC assessment was faster, more
objective, and a superior predictor of outcomes. However, this approach has not yet been
applied systematically to infants and children.For more than 50 years, uncuffed tracheal
tubes have been commonly used for intubation in children under 8 years of age because of the
anatomy of the pediatric larynx and the fear that the cuff will cause airway mucosal injury,
leading to subglottic stenosis. However, since 2009, it is registered and available a new
cuffed tracheal tube (TT) with an anatomically designed high volume-low pressure tube cuff,
with a recommendation chart for tube size selection has recently become available for
pediatric anesthesia.Weiss and colleagues enrolled 2246 patients in a randomized multi-centre
trial and reported no increase of risk for post-extubation stridor with the use of the new
microcuffed.Considering that microaspiration of contaminated oral secretions is one of the
mechanisms leading to VAP and VAT, the use of cuffed TTs may be beneficial in VAP prevention
as the superior tracheal seal may decrease the incidence of micro-aspiration. However, no
study evaluated the incidence of VAP with the use of cuffed tracheal tubes is published since
now.Despite of these new evidence, the use of uncuffed tube in neonatal and pediatric
critical care still remain very common to minimize minor complications (i.e. mucosal damage
due to the cuff), and consequently the use of cuffed or uncuffed tubes is equally
recommended.The management of anesthesia according to standards procedures of the Bergamo
anesthesia department is shifting from the uncuffed tubes only to microcuffed tubes, and it
is aim of the present study to monitor this transition measuring the performance of the two
TTs in terms of incidence of VAP and VAT (according to the CDC old definition) and in term of
incidence of VAC and IVAC (according to CDC new definition).The CDC definition was used to
identify patients with VAP and VAT. The CDC definition of VAP for infants < 1 y.o. and
children > 1 or < 12 y.o. are based on clinical and X-ray criteria. The CDC definition of
Tracheitis are based on absence of clinical and radiographic evidence of pneumonia and the
following criteria: positive culture obtained by deep tracheal aspirate and 2 signs of
symptoms with no recognizable cause [such as fever (>38.5°C), cough, new or increased sputum
production, rhonchi, or wheezing].
The new CDC definition is used to identify patients with VAC and IVAC. The new definitions
includes all associated complications (infection included) related to mechanical ventilation
and exclude X-ray criteria.
VAP, VAT, VAC, IVAC rate, expressed as the number of VAP/VAT/VAC/IVAC episodes per 1000
mechanical ventilator days (VAP/1000 MV days), were calculated for phase 1 and phase 2.