Clinical trial NCT04668742: Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients
Official title: 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 "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy
Mechanical Ventilation Complication
Keywords: tracheostomy
airway
complications
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: Plasticos de Santander Ltda PLADESAN
First posted: 2020-12-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of mis-alignment of tracheostomy tube
timeFrame: 72 hours after tracheostomy installation
Secondary outcomes:
measure: Presence of complications of tracheostomy
timeFrame: 72 hours after tracheostomy installation
Other outcomes:
measure: Presence of skin lesion
timeFrame: 72 hours after tracheostomy installation
Locations:
city: Piedecuesta
country: Colombia
facility: Hospital Internacional de Colombia
state: Santander
Study officials:
affiliation: Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia
name: Mauricio Orozco-Levi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: