NCT03573609

Evaluation of the Effectiveness and Safety of Supratube Device

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Fundación Cardiovascular de Colombia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Supranav	Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation

Timeline

• Start date: 2018-05-29
• Primary completion: 2019-12-01
• Completion: 2020-01-20
• First posted: 2018-06-29
• Last updated: 2022-04-20

Locations

1 site across 1 country: Colombia