Evaluation of the Effectiveness and Safety of Supratube Device

Fundación Cardiovascular de Colombia108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

108

Conditions

Intensive Critical Unit Pneumonia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Intubated adult patients with mechanical ventilation. * To have a closest responsible relative * Integrity of the airways Exclusion Criteria: * Need of orofacial, cervical or respiratory tract surgical procedures * Patients with tracheostomy * Shock, * Local or systemic uncontrolled infection * Blood dyscrasia, neoplastic diseases * Physiological alteration * Acute or chronic decompensated pathology that is not controlled at the time of selection.

Outcomes

Primary Outcomes

Ventilator associated events

A group of all the conditions that result in a significant and sustained deterioration in oxygenation, defined as a greater than 20% increase in the daily minimum fraction of inspired oxygen or an increase of at least 3 cm H2O in the daily minimum positive end-expiratory pressure (PEEP) to maintain oxygenation. It is imperative to understand that both infectious conditions (such as tracheitis, tracheobronchitis, and pneumonia) and noninfectious conditions (such as atelectasis, pulmonary embolism, pulmonary edema, ventilator-induced lung injury, and others) may fulfill this VAE definition.

Time frame: 24 hours after extubation

Secondary Outcomes

Adverse events

Number of patientes with Bleeding and lacerations in the oropharynx