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

NCT ID: NCT04668742

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-25
• Study Completion Date: 2022-01-25

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.

Conditions

Tracheostomy; Mechanical Ventilation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm 1: DYNAtraq - tracheostomy fixation device

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

Group Type: EXPERIMENTAL

DYNAtraq

Intervention Type: DEVICE

Tracheostomy alignment with DYNAtraq

Arm 2: Usual management of tracheostomy

No interventions will be used additional to usual management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DYNAtraq

Tracheostomy alignment with DYNAtraq

Intervention Type: DEVICE

Other Intervention Names

tracheostomy fixation device

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role: collaborator

Plasticos de Santander Ltda PLADESAN

UNKNOWN

Sponsor Role: collaborator

Fundación Cardiovascular de Colombia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauricio Orozco-Levi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fundacion Cardiovascular de Colombia- Hospital internacional de Colombia

Locations

Hospital Internacional de Colombia

Piedecuesta, Santander Department, Colombia

Countries

Colombia

Other Identifiers

656677758319

Identifier Type: -

Identifier Source: org_study_id