Multicenter, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness and Safety of the New Supratube Invention Device to Prevent Pneumonia Associated With Mechanical Ventilation: " Supra-nav Project "
Multicenter, Controlled, Randomized Clinical Trial to Evaluate the Effectiveness and Safety of the New Supratube Invention Device to Prevent Pneumonia Associated With Mechanical Ventilation: " Supra-nav Project "
Purpose of the trial:
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Clinical evaluation of sinus, oropharyngeal, tracheal, bronchial or pulmonary infections during orotracheal intubation and hospital admission.
Secondary endpoints:
Volume of oropharyngeal secretions aspirated per unit of time (for 24 hours) by the SupraTube and Complications during the use of the SupraTube device: erosions, lacerations, Bleeding, displacement, migration, need for withdrawal.
Inclusion criteria:
Exclusion criteria:
Trial treatment:
Intervention:
Aspiration of secretions with the supranav device
Control:
Usual respiratory care
Expected sample size, enrollment and expected number of centers:
Sample size = 108
Recruitment start date:
Recruitment end date:
Follow-up end date:
Number of centers: 2
Statistical considerations:
Inclusion Criteria:
Exclusion Criteria: