Evaluation of the Effectiveness and Safety of Supratube Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2020-01-20

Brief Summary

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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

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Detailed Description

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Conditions

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Intensive Critical Unit Pneumonia Aspiration Prevention and Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control

Usual respiratory care

Group Type NO_INTERVENTION

No interventions assigned to this group

Supranav

Respiratory care with "supranav" which is a continuous supraglottic suction device

Group Type ACTIVE_COMPARATOR

Supranav

Intervention Type DEVICE

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

Interventions

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Supranav

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No