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

A Clinical, Controlled, Randomized Trial to Evaluate the Efficacy and Safety of the New Dynatraq Invention Device to Prevent Complications Associated With Tracheostomy Tubes in Mechanically Ventilated Patients: " Dynatraq-2 Study "

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.

Study Overview

• Status: Completed
• Conditions: Tracheostomy; Mechanical Ventilation Complication
• Intervention / Treatment: Device: DYNAtraq

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 facilitate the improvement of the patient, facilitate early rehabilitation, reduce sedation and analgesia requirements, and reduce the length of stay in the ICU and the days of mechanical ventilation (MV). However, tracheostomy is associated with various complications, from mispositioning and accidental decannulation, to hemoptysis, tracheal fistulas, air leaks, and ventilatory difficulties. In a pre-post quasi-experimental study where the effect of the DYNAtraq technological innovation device on tracheostomy fixation and alignment was evaluated, it was found that it can correct 83% of cases, which contrasts with only 2% when they did not have the device. (p <0.01). This previous study allowed us to conclude that technological innovation through DYNAtraq is pertinent, relevant and effective to correct the position of tracheostomy tubes in patients hospitalized in the ICU and under mechanical ventilation.

Objective: To evaluate the efficacy and safety of the DYNAtraq medical device to keep tracheostomy tubes in correct alignment and fixation in adult patients with tracheostomy hospitalized in the ICU and under invasive mechanical ventilation.

Methodology: Randomized, controlled clinical trial (two-parallel arm), assigned in a 1: 1 ratio, in a sample of 74 patients mechanically ventilated in intensive care unit (37 in intervention group and 37 patients in control group). This study is conducted in two centers for intensive care patients in two Colombian cities and

The patients randomized to the intervention group will have the external fixation system for the tracheostomy installed, which is a non-invasive plastic device, from the start of the tracheostomy to ventilatory weaning. Patients in the control group will receive the usual management of the tracheostomy given in ICU. To evaluate alignment , the cephalo-caudal (C-C) and lateral-lateral (L-L) angles will be evaluated through photographs and analyzed with the SAPO application. The mean values of the angles were obtained in degrees and their 95% confidence intervals. Angular means were compared using the paired Student's t test.

Expected Results: The DYNAtraq device is expected to be effective in improving the proper fixation, orientation, and alignment of the tracheostomy tube in mechanically ventilated patients, reducing the complications of lacerations, bleeding, decannulation, and respiratory infectious complications.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Santander
    • Piedecuesta, Santander, Colombia, 683071
      • Hospital Internacional de Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: DYNAtraq - tracheostomy fixation device; Use of DYNatraq installed in chest with skin adhesive and fixed to tracheostomy tube	Device: DYNAtraq; Tracheostomy alignment with DYNAtraq; Other Names: tracheostomy fixation device
No Intervention: Arm 2: Usual management of tracheostomy; No interventions will be used additional to usual management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of complications of tracheostomy	Evidence of any complication due to tracheostomy (infections, bleeding, extubation, death)	72 hours after tracheostomy installation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of skin lesion	Safety of the device in skin (adhesive)	72 hours after tracheostomy installation

Collaborators and Investigators

• Sponsor: Fundación Cardiovascular de Colombia
• Collaborators: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS); Plasticos de Santander Ltda PLADESAN
• Investigators: Principal Investigator: Mauricio Orozco-Levi, Ph.D, Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: complications; airway; tracheostomy
• Other Study ID Numbers: 656677758319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No