Skip to main content
OpenTrials
Completed

NCT Number: NCT03573609

Evaluation of the Effectiveness and Safety of Supratube Device

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Cardiovascular de Colombia

Piedecuesta, Santander Department, 681011, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supranav

Device

Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation

Primary outcomes

  1. Ventilator associated events

    Time frame: 24 hours after extubation

    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.

Secondary outcomes

  1. Adverse events

    Time frame: 24 hours after extubation

    Number of patientes with Bleeding and lacerations in the oropharynx

Sponsors and collaborators

Lead sponsor

Fundación Cardiovascular de Colombia

Other

Registry information

Official study 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 "

Acronym: SUPRANAV

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 29, 2018
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.