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

NCT03129893 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 242

Last updated 2023-08-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Mirco Nacoti, MD · ASST Papa Giovanni XXIII di Bergamo

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-03-08
Completion
2019-06-30
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129893 on ClinicalTrials.gov