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

NCT03129893 | Completed FDA Device

• 1 other identifier: PICU-BG-TT
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation; Pediatric Surgery

Outcome Measures

Primary Outcomes (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

  At PICU discharge, an average of 2 weeks

Secondary Outcomes (5)

• The incidence rate difference of VAC and IVAC

  At PICU discharge, an average of 2 weeks

• The reintubation rates for leakage

  At PICU discharge, an average of 2 weeks

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

  At PICU discharge, an average of 2 weeks

• The duration of intubation

  At PICU discharge, an average of 2 weeks

• The length of PICU stay

  At PICU discharge, an average of 2 weeks

Study Arms (2)

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.

Device: Cuffed tracheal tubes

Interventions

Cuffed tracheal tubes DEVICE

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

Patients intubated with cuffed tracheal tubes

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Parents refused consent.

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (1)

Pediatric intensive care unit - ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

Study Officials

• Mirco Nacoti, MD

  ASST Papa Giovanni XXIII di Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: April 26, 2017
• Study Start: January 1, 2017
• Primary Completion: March 8, 2019
• Study Completion: June 30, 2019
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)