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Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients

NCT04668742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-04-06

No results posted yet for this study

Summary

Although tracheostomy is a common technique in Intensive Care Units (ICU), its complications can be frequent (between 5% to 40%). Inadequate fixation could favor decannulation, as well as incorrect alignment of the tracheostomy with respect to the tracheal axis could favor the appearance of tissue alterations such as ulcers, bleeding or fistulas, as well as obstruction of the ventilatory obstruction. Having a device that is effective in fixation and alignment could help in reducing tracheostomy complications, so this study aims to evaluate the effect and safety of a fixation device for tracheostomy through a randomized clinical trial.

Conditions

  • Tracheostomy
  • Mechanical Ventilation Complication

Interventions

DEVICE

DYNAtraq

Tracheostomy alignment with DYNAtraq

Sponsors & Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Plasticos de Santander Ltda PLADESAN

    collaborator UNKNOWN

  • Fundación Cardiovascular de Colombia

    lead OTHER

Principal Investigators

  • Mauricio Orozco-Levi, Ph.D · Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2021-05-25
Completion
2022-01-25

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04668742 on ClinicalTrials.gov