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Evaluation of the Effectiveness and Safety of Supratube Device

NCT03573609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-04-20

No results posted yet for this study

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

Conditions

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

Interventions

DEVICE

Supranav

Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation

Sponsors & Collaborators

  • Fundación Cardiovascular de Colombia

    lead OTHER

Principal Investigators

  • Alba L Ramirez Sarmiento, PhD · Fundación Cardiovascular de Colombia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-12-01
Completion
2020-01-20

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573609 on ClinicalTrials.gov