Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device (Supratube)

July 9, 2018 updated by: Fundación Cardiovascular de Colombia

Evaluation of the Effectiveness and Safety of an Own-invention System for Continuous Supraglottic Aspiration in Intubated and Mechanically Ventilated Patients: the "SUPRAtube" Device

Purpose of the trial: Evaluate the efficacy and safety of the device of self-invention of continuous oropharyngeal aspiration denominated "SUPRAtube" in patients with orotracheal intubation and mechanical ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Santander
      • Piedecuesta, Santander, Colombia, 681011
        • Fundacion Cardiovascular de Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Endotracheal intubation and invasive mechanical ventilation,

Exclusion Criteria:

  • Immediate postoperative oral cavity.
  • Traumatic oral cavity injury.
  • Platelet count less than 50000.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Supratube
Patient with orotracheal intubation and supratube device
Device: Supratube
Aspiration of orotracheal secretions with supratube device
Other: Reference
Usual aspiration with any other device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aspirated secretions
Time Frame: 24 hours after intubation
volume of aspirated secretions
24 hours after intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 24 hours after intubation
Adverse events related to supratube device use
24 hours after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Cardiovascular de Colombia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2016

Primary Completion (Actual)

December 12, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 9, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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