Evaluation of the Effectiveness and Safety of Supratube Device

Study Overview
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Brief Summary
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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

Official Title
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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 

Conditions
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Intensive Critical Unit, Pneumonia, Aspiration, Prevention and Control

Intervention / Treatment
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* Device: Supranav


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual respiratory care | |
| Active Comparator: Supranav<br>Respiratory care with supranav which is a continuous supraglottic suction device | Device: Supranav<br>* Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of patientes with Bleeding and lacerations in the oropharynx | 24 hours after extubation |