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IntubationPICU-BG-TTNCT03129893

Cuffed Versus Uncuffed Tracheal Tubes in PICU (PICU-BG-TT Study)

An observational study of Intubation and Pediatric Surgery, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.

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

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. Read more about this study

Who is it for?
Ages Up to 5 years
Conditions the study is for
Intubation, Pediatric Surgery
What is being tested?
Cuffed tracheal tubes
How many people
242 participants
Where
1 siteItaly
Study dates
1 Jan 2017to 30 Jun 2019
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 Up to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric patient in need intubation for cardiac surgery and transferred to the PICU.

Who may be able to join

  • Neonates >35/40 gestation;
  • Expected to require ventilation for > 24 hours;
  • Age: 0 - 5 year.

Who cannot join

  • Parents refused consent.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Pediatric intensive care unit - ASST Papa Giovanni XXIII

    Bergamo, BG, 24127

Other trials in Italy

About this study

Official title: Ventilator Associated Complications in Neonate and Small Infant Undergoing Cardiac Surgery Using Cuffed and Uncuffed Tracheal Tubes. The PICU-BG-TT Study

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.

Read the detailed 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.

Being tested
Cuffed tracheal tubes

What participants receive

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

  • Cuffed tracheal tubesDevice

    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

Study groups in NCT03129893
Study groupRoleWhat they receive
Patients intubated with uncuffed tracheal tubesPortex uncuffed TT sizes selected according to local institutional guidelines. Tracheal intubation performed under direct laryngoscopy by the oral or nasal route, without or with the use of bougies or stylets. TT insertion depth managed according to institutional guidelines in uncuffed TTs.
Patients intubated with cuffed tracheal tubesCuffed TT sizes selected as follows: ID 3.0 mm for birth (>3 kg body weight) to < 8 months; ID 3.5 mm for 8 to < 12 months (Salgo, Schmitz et al. 2006). Tracheal intubation performed under direct laryngoscopy by the oral or nasal route, without or with the use of bougies or stylets. TT insertion depth managed according to the depth marking in cuffed TTs.
Receives: Device: Cuffed tracheal tubes

What is being measured

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

  1. 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

    Measured: At PICU discharge, an average of 2 weeks

Secondary outcomes (5)
  1. The incidence rate difference of VAC and IVAC

    The incidence rate difference of VAC and IVAC

    Measured: At PICU discharge, an average of 2 weeks

  2. The reintubation rates for leakage

    The reintubation rates for leakage

    Measured: At PICU discharge, an average of 2 weeks

  3. The post-extubation airway morbidity (post-extubation stridor)

    The post-extubation airway morbidity (post-extubation stridor)

    Measured: At PICU discharge, an average of 2 weeks

  4. The duration of intubation

    The duration of intubation

    Measured: At PICU discharge, an average of 2 weeks

  5. The length of PICU stay

    The length of PICU stay

    Measured: At PICU discharge, an average of 2 weeks

Timeline

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

  1. First posted26 Apr 2017
  2. Study start1 Jan 2017
  3. Primary completion8 Mar 2019
  4. Study completion30 Jun 2019

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
Other
Time perspective
Prospective
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03129893
Sponsor's protocol ID
PICU-BG-TT
Acronym
PICU-BG-TT
Status last verified
Aug 2023
First submitted
1 Mar 2017
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation and Pediatric Surgery, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.

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 3 inclusion and 1 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The incidence rate difference of VAP and VAT between microcuffed TTs and uncuffed TTs (time frame: At PICU discharge, an average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Aug 2023.

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