Evaluation of the Effectiveness and Safety of Supratube Device

Not Applicable

Completed

• Conditions: Pneumonia; Aspiration; Prevention and Control; Intensive Critical Unit
• Interventions: Device: Supranav

• Registration Number: NCT03573609
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-05-10
• Study Start: 2018-05-29
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-20
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supranav	Supranav	Respiratory care with "supranav" which is a continuous supraglottic suction device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events	24 hours after extubation	Number of patientes with Bleeding and lacerations in the oropharynx

Trial Locations

Locations (1)

Fundación Cardiovascular de Colombia; 🇨🇴 Piedecuesta, Santander, Colombia