TracheostomyDYNAtraqNCT04668742
Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients
A study testing DYNAtraq in people with Tracheostomy and Mechanical Ventilation Complication, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Mechanical Ventilation Complication
- What is being tested?
- DYNAtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteColombia
- Study dates
- 25 Nov 2019to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Indication for a tracheostomy
- Signature of informed consent
Who cannot join
- Mediastinitis
- Open chest
- Chest skin infection /burns anterior region of the thorax
- Patients requiring reanimation
- Active phase of COVID-19
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Internacional de Colombia
Piedecuesta, Santander Department, 683071
About this study
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 "
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.
Read the 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.
- Conditions
- Tracheostomy, Mechanical Ventilation Complication
- Being tested
- DYNAtraq
- Keywords
- tracheostomy, airway, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DYNAtraqDevice
Also called tracheostomy fixation device
Tracheostomy alignment with DYNAtraq
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: DYNAtraq - tracheostomy fixation device | Experimental | Use of DYNatraq installed in chest with skin adhesive and fixed to tracheostomy tube Receives: Device: DYNAtraq |
| Arm 2: Usual management of tracheostomy | No intervention | No interventions will be used additional to usual management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours after tracheostomy installation
Secondary outcomes (1)
Presence of complications of tracheostomy
Evidence of any complication due to tracheostomy (infections, bleeding, extubation, death)
Measured: 72 hours after tracheostomy installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start25 Nov 2019
- Primary completion25 May 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Plasticos de Santander Ltda PLADESAN
- Responsible party
- Sponsor
- Investigators
- Mauricio Orozco-Levi, Ph.D, Principal investigator, Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668742
- Sponsor's protocol ID
- 656677758319
- Acronym
- DYNAtraq
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 "
- ClinicalTrials.gov ID
- NCT04668742
- Acronym / sponsor ID
- DYNAtraq / 656677758319
- Conditions
- Tracheostomy, Mechanical Ventilation Complication
- Keywords
- tracheostomy, airway, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Plasticos de Santander Ltda PLADESAN
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: DYNAtraq - tracheostomy fixation device | Experimental | Device: DYNAtraqUse of DYNatraq installed in chest with skin adhesive and fixed to tracheostomy tube |
| Arm 2: Usual management of tracheostomy | No intervention | –No interventions will be used additional to usual management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age
- Indication for a tracheostomy
- Signature of informed consent
Key exclusion criteria (5 listed)
- Mediastinitis
- Open chest
- Chest skin infection /burns anterior region of the thorax
- Patients requiring reanimation
- Active phase of COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DYNAtraqAlso: tracheostomy fixation deviceTracheostomy alignment with DYNAtraq | Device | Arm 1: DYNAtraq - tracheostomy fixation device |
Primary outcome
Presence of mis-alignment of tracheostomy tube
Time frame: 72 hours after tracheostomy installation
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
1 secondary outcome
Presence of complications of tracheostomy
Time frame: 72 hours after tracheostomy installation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio Orozco-Levi, Ph.D principal investigator
Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DYNAtraq in people with Tracheostomy and Mechanical Ventilation Complication, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of mis-alignment of tracheostomy tube (time frame: 72 hours after tracheostomy installation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.