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Evaluation of the Effectiveness and Safety of Supratube Device — SUPRANAV  

Pneumonia Clinical Trial

Official title:
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 "

Clinical Trial Summary

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: - Adult patient - Orotracheal intubation ≤ 72 hours - Hospitalized in ICU - integrity of upper airways Exclusion criteria: - International patients - Coagulopathic patients - oncology patients - patients with maxillofacial surgery - Absence of close responsible family member - Tracheostomy, shock, local or systemic non-controlled infection 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: - Intention to treat analysis - The primary outcomes will be analyzed using

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03573609
Study type Interventional
Source Fundación Cardiovascular de Colombia
Contact
Status Completed
Phase N/A
Start date May 29, 2018
Completion date January 20, 2020
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