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 "

Status Completed

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

Related Conditions & MeSH terms

• Aspiration
• Intensive Critical Unit
• Pneumonia
• Prevention and Control

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