NCT03573609

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2018

Enrollment Period

1.5 years

First QC Date

May 10, 2018

Last Update Submit

April 18, 2022

Conditions

Intensive Critical UnitPneumoniaAspirationPrevention and Control

Outcome Measures

Primary Outcomes (1)

  • Ventilator associated events

    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.

    24 hours after extubation

Secondary Outcomes (1)

  • Adverse events

    24 hours after extubation

Study Arms (2)

Control

NO INTERVENTION

Usual respiratory care

Supranav

ACTIVE COMPARATOR

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

Device: Supranav

Interventions

SupranavDEVICE

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

Supranav

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubated adult patients with mechanical ventilation.
  • To have a closest responsible relative
  • Integrity of the airways

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Cardiovascular de Colombia

Piedecuesta, Santander Department, 681011, Colombia

Location

Related Publications (1)

  • Orozco-Levi M, Tiga-Loza DC, Aya O, Reyes CF, Caceres-Rivera D, Espitia A, Rey D, Pedrozo Arias KP, Pizarro C, Sanabria-Barrera SM, Serrano-Diaz N, Castillo VR, Ramirez-Sarmiento A. A Novel Supraglottic Suction Device in Mechanically Ventilated Patients: A Randomized Controlled Trial. Med Devices (Auckl). 2025 Mar 24;18:201-212. doi: 10.2147/MDER.S499924. eCollection 2025.

    PMID: 40161252DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Alba L Ramirez Sarmiento, PhD

    Fundación Cardiovascular de Colombia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2018

First Posted

June 29, 2018

Study Start

May 29, 2018

Primary Completion

December 1, 2019

Study Completion

January 20, 2020

Last Updated

April 20, 2022

Record last verified: 2018-04

Locations

CO(1)