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

Fundación Cardiovascular de Colombia

Status: Completed

Conditions: Intensive Critical Unit; Aspiration; Prevention and Control; Pneumonia

Treatments: Device: Supranav

Study type: Interventional

Funder types: Other

Identifiers

NCT03573609

0001

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

108 participants in 2 patient groups

Control

No Intervention group

Description:

Usual respiratory care

Supranav

Active Comparator group

Description:

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

Treatment:

Device: Supranav