Status:
COMPLETED
Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborating Sponsors:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Plasticos de Santander Ltda PLADESAN
Conditions:
Tracheostomy
Mechanical Ventilation Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 al...
Detailed Description
Introduction: Tracheostomy is one of the most frequently required surgical techniques for the management of hospitalized patients in Intensive Care Units (ICU). This procedure is justified to facilita...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18 years of age
- Indication for a tracheostomy
- Signature of informed consent
- Exclusion criteria:
- Mediastinitis
- Open chest
- Chest skin infection /burns anterior region of the thorax
- Patients requiring reanimation
- Active phase of COVID-19
Exclusion
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04668742
Start Date
November 25 2019
End Date
January 25 2022
Last Update
April 6 2022
Active Locations (1)
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1
Hospital Internacional de Colombia
Piedecuesta, Santander Department, Colombia, 683071