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

• ClinicalTrials.gov Identifier: NCT03573609
• Recruitment Status: Unknown
• First Posted: June 29, 2018
• Last Update Posted: July 10, 2018
• Sponsor: Fundación Cardiovascular de Colombia
• Information provided by (Responsible Party): Fundación Cardiovascular de Colombia

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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

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

• Principal Investigator: Alba L Ramirez Sarmiento, PhD; Fundación Cardiovascular de Colombia

More Information

• Responsible Party: Fundación Cardiovascular de Colombia
• ClinicalTrials.gov Identifier: NCT03573609
• Other Study ID Numbers: 0001
• First Posted: June 29, 2018
• Last Update Posted: July 10, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases