Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Effectiveness and Safety of Supratube Device (SUPRANAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03573609
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación Cardiovascular de Colombia

Brief 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

Condition or disease Intervention/treatment Phase
Intensive Critical Unit Pneumonia Aspiration Prevention and Control Device: Supranav Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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 "
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
No Intervention: Control
Usual respiratory care
Active Comparator: Supranav
Respiratory care with "supranav" which is a continuous supraglottic suction device
Device: Supranav
Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation




Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse events [ Time Frame: 24 hours after extubation ]
    Number of patientes with Bleeding and lacerations in the oropharynx



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573609


Contacts
Layout table for location contacts
Contact: Diana I Cáceres Rivera, PhD +576394040 ext 1*056 dianacaceresrivera@gmail.com
Contact: Alba L Ramirez Sarmiento, PhD +576394040 ext 1*056 alba.ramirez.sarmiento@gmail.com

Locations
Layout table for location information
Colombia
Fundación Cardiovascular de Colombia Recruiting
Piedecuesta, Santander, Colombia, 681011
Contact: Diana I Cáceres Rivera, PhD    +576394040 ext 1*056    dianacaceresrivera@gmail.com   
Principal Investigator: Alba L Ramirez Sarmiento, PhD         
Sub-Investigator: Mauricio A Orozo Levi, PhD         
Sub-Investigator: Camilo E Pizarro Gómez, MD         
Sub-Investigator: Diana I Cáceres Rivera, PhD         
Sub-Investigator: Diana Rey, MD         
Sub-Investigator: Carlos F Reyes Martinez, MD         
Sub-Investigator: Anderson Bermon Angarita, MsC         
Sponsors and Collaborators
Fundación Cardiovascular de Colombia
Investigators
Layout table for investigator information
Principal Investigator: Alba L Ramirez Sarmiento, PhD Fundación Cardiovascular de Colombia

Layout table for additonal information
Responsible Party: Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier: NCT03573609     History of Changes
Other Study ID Numbers: 0001
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections