Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04668742 |
| Other study ID # |
656677758319 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2019 |
| Est. completion date |
January 25, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Fundación Cardiovascular de Colombia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
