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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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.
- Conditions
- Intubation, Pediatric Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Patients intubated with uncuffed tracheal tubes | Portex 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 tubes | Cuffed 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.
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)
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
The reintubation rates for leakage
The reintubation rates for leakage
Measured: At PICU discharge, an average of 2 weeks
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
The duration of intubation
The duration of intubation
Measured: At PICU discharge, an average of 2 weeks
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.
- First posted26 Apr 2017
- Study start1 Jan 2017
- Primary completion8 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirco Nacoti, MD, Principal investigator, ASST Papa Giovanni XXIII di Bergamo
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Associated Complications in Neonate and Small Infant Undergoing Cardiac Surgery Using Cuffed and Uncuffed Tracheal Tubes. The PICU-BG-TT Study
- ClinicalTrials.gov ID
- NCT03129893
- Acronym / sponsor ID
- PICU-BG-TT / PICU-BG-TT
- Conditions
- Intubation, Pediatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients intubated with uncuffed tracheal tubes | – | –Portex 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 tubes | – | Device: 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patient in need intubation for cardiac surgery and transferred to the PICU.
Key inclusion criteria (3 listed)
- Neonates >35/40 gestation;
- Expected to require ventilation for > 24 hours;
- Age: 0 - 5 year.
Key exclusion criteria (1 listed)
- Parents refused consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuffed tracheal tubesCuffed tracheal tube with an anatomically designed high volume - low pressure tube cuff, with a recommendation chart for tube size selection available for pediatric anesthesia | Device | Patients intubated with cuffed tracheal tubes |
Primary outcome
The incidence rate difference of VAP and VAT between microcuffed TTs and uncuffed TTs
Time frame: At PICU discharge, an average of 2 weeks
The incidence rate difference of VAP and VAT between microcuffed TTs and uncuffed TTs
5 secondary outcomes
The incidence rate difference of VAC and IVAC
Time frame: At PICU discharge, an average of 2 weeks
The reintubation rates for leakage
Time frame: At PICU discharge, an average of 2 weeks
The post-extubation airway morbidity (post-extubation stridor)
Time frame: At PICU discharge, an average of 2 weeks
The duration of intubation
Time frame: At PICU discharge, an average of 2 weeks
The length of PICU stay
Time frame: At PICU discharge, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirco Nacoti, MD principal investigator
ASST Papa Giovanni XXIII di Bergamo
1 site in 1 country: see every site and its status.
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.