Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date June 30, 2019
Est. primary completion date March 8, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria: - Neonates >35/40 gestation; - Expected to require ventilation for > 24 hours; - Age: 0 - 5 year. Exclusion Criteria: • Parents refused consent.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cuffed tracheal tubes
Cuffed tracheal tube with an anatomically designed high volume - low pressure tube cuff, with a recommendation chart for tube size selection available for pediatric anesthesia

Locations

Country Name City State
Italy Pediatric intensive care unit - ASST Papa Giovanni XXIII Bergamo BG

Sponsors (1)

Lead Sponsor Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence rate difference of VAP and VAT between microcuffed TTs and uncuffed TTs The incidence rate difference of VAP and VAT between microcuffed TTs and uncuffed TTs At PICU discharge, an average of 2 weeks
Secondary The incidence rate difference of VAC and IVAC The incidence rate difference of VAC and IVAC At PICU discharge, an average of 2 weeks
Secondary The reintubation rates for leakage The reintubation rates for leakage At PICU discharge, an average of 2 weeks
Secondary The post-extubation airway morbidity (post-extubation stridor) The post-extubation airway morbidity (post-extubation stridor) At PICU discharge, an average of 2 weeks
Secondary The duration of intubation The duration of intubation At PICU discharge, an average of 2 weeks
Secondary The length of PICU stay The length of PICU stay At PICU discharge, an average of 2 weeks
See also
  Status Clinical Trial Phase
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Suspended NCT04253795 - Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery N/A
Completed NCT02864017 - Immuno Nutrition by L-citrulline for Critically Ill Patients N/A
Completed NCT02900807 - CT-scan Airways Mensuration - Correlation to External Measurements
Completed NCT01823328 - Ketamine Versus Etomidate for Rapid Sequence Intubation Phase 4
Completed NCT02350933 - Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation N/A
Completed NCT01170455 - Nasal Intubation Using the Blind Intubation Device N/A
Completed NCT00980590 - Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground N/A
Completed NCT05515107 - The Laryngoscopic View With C-MAC Videolaryngoscope Miller Blade Lifting the Epiglottis or the Vallecula in Children N/A
Completed NCT06249659 - Impact of Extubation Location After Surgery on Perioperative Times
Completed NCT03677505 - KoMAC Videolaryngoscope for Double-lumen Intubation N/A
Completed NCT03328182 - Assessment of an Oral Endotracheal Subglottic Tube Holder N/A
Recruiting NCT02277405 - Pediatric Intubation During Resuscitation N/A
Recruiting NCT02277652 - Endotracheal Intubation Devices N/A
Recruiting NCT02073786 - Rigid Video Stylet Vs Conventional Lightwand Intubation N/A
Completed NCT02277418 - Venner a.p. Advance Video Laryngoscope N/A
Completed NCT01003327 - Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 Phase 4
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00783731 - Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED) N/A
Recruiting NCT03887897 - First Attempt Intubation Rate With Airtraq vs Macintosh Direct Laryngoscope N/A