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

NCT04668742 | Completed

• 1 other identifier: 656677758319
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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 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

Keywords

tracheostomy; airway; complications

Outcome Measures

Primary Outcomes (1)

• Presence of mis-alignment of tracheostomy tube

  Deviation from 95° angle of tracheostomy tube (cephalo-caudal (C-C) and lateral-lateral (L-L) angles) No evidence of alignment of tube though bronchoscopy

  72 hours after tracheostomy installation

Secondary Outcomes (1)

• Presence of complications of tracheostomy

  72 hours after tracheostomy installation

Other Outcomes (1)

• Presence of skin lesion

  72 hours after tracheostomy installation

Study Arms (2)

Arm 1: DYNAtraq - tracheostomy fixation device

EXPERIMENTAL

Use of DYNatraq installed in chest with skin adhesive and fixed to tracheostomy tube

Device: DYNAtraq

Arm 2: Usual management of tracheostomy

NO INTERVENTION

No interventions will be used additional to usual management

Interventions

DYNAtraq DEVICE

Tracheostomy alignment with DYNAtraq

Also known as: tracheostomy fixation device

Arm 1: DYNAtraq - tracheostomy fixation device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Indication for a tracheostomy
• Signature of informed consent

You may not qualify if:

• Mediastinitis
• Open chest
• Chest skin infection /burns anterior region of the thorax
• Patients requiring reanimation
• Active phase of COVID-19

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator
• Plasticos de Santander Ltda PLADESAN: collaborator

Study Sites (1)

Hospital Internacional de Colombia

Piedecuesta, Santander Department, 683071, Colombia

Location

Study Officials

• Mauricio Orozco-Levi, Ph.D

  Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: masking of the intervention and control groups in the statistical analysis of the data, which will be represented as group 0 and 1, without identifying whether they are control or intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 16, 2020
• Study Start: November 25, 2019
• Primary Completion: May 25, 2021
• Study Completion: January 25, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)