Evaluation of the Effectiveness and Safety of Supratube Device

Pneumonia Clinical Trial

— SUPRANAV  

Official 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 "

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573609
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: April 2018
• Source: Fundación Cardiovascular de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Supranav
Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation

Locations

Country	Name	City	State
Colombia	Fundación Cardiovascular de Colombia	Piedecuesta	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

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