SUPRANAV: Evaluation of the Effectiveness and Safety of Supratube Device

Sponsor

Fundación Cardiovascular de Colombia (Other)

Overall Status

Completed

CT.gov ID

NCT03573609

Collaborator

(none)

108

Enrollment

Location

Arms

19.7

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Actual 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

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Jan 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

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

Ventilator associated events [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

Adverse events [24 hours after extubation]
Number of patientes with Bleeding and lacerations in the oropharynx

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Fundación Cardiovascular de Colombia	Piedecuesta	Santander	Colombia	681011

Sponsors and Collaborators

Fundación Cardiovascular de Colombia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundación Cardiovascular de Colombia

ClinicalTrials.gov Identifier:

NCT03573609

Other Study ID Numbers:

0001

First Posted:

Jun 29, 2018

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Study Results

No Results Posted as of Apr 20, 2022