Pneumonia Clinical Trial
— SUPRANAVOfficial 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 "
NCT number | NCT03573609 |
Other study ID # | 0001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 29, 2018 |
Est. completion date | January 20, 2020 |
Verified date | April 2018 |
Source | Fundación Cardiovascular de Colombia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 108 |
Est. completion date | January 20, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Fundación Cardiovascular de Colombia | Piedecuesta | Santander |
Lead Sponsor | Collaborator |
---|---|
Fundación Cardiovascular de Colombia |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adverse events | Number of patientes with Bleeding and lacerations in the oropharynx | 24 hours after extubation |
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