Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date January 25, 2022
Est. primary completion date May 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
DYNAtraq
Tracheostomy alignment with DYNAtraq

Locations

Country Name City State
Colombia Hospital Internacional de Colombia Piedecuesta Santander

Sponsors (3)

Lead Sponsor Collaborator
Fundación Cardiovascular de Colombia Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Plasticos de Santander Ltda PLADESAN

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Other Presence of skin lesion Safety of the device in skin (adhesive) 72 hours after tracheostomy installation
Primary 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 Presence of complications of tracheostomy Evidence of any complication due to tracheostomy (infections, bleeding, extubation, death) 72 hours after tracheostomy installation
See also
  Status Clinical Trial Phase
Recruiting NCT05030337 - Optimising Ventilation in Preterms With Closed-loop Oxygen Control N/A
Completed NCT05144607 - Impact of Inspiratory Muscle Pressure Curves on the Ability of Professionals to Identify Patient-ventilator Asynchronies N/A
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT05084976 - Parental Perception of COVID-19 Vaccine in Technology Dependent Patients
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Completed NCT04429399 - Lowering PEEP: Weaning From High PEEP Setting N/A
Completed NCT02249039 - Intravenous Clonidine for Sedation in Infants and Children Who Are Mechanically Ventilated - Dosing Finding Study Phase 1
Recruiting NCT02071524 - Evaluation of the Effects of Fluid Therapy on Respiratory Mechanics N/A
Completed NCT01114022 - Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane N/A
Completed NCT00893763 - Strategies To Prevent Pneumonia 2 (SToPP2) Phase 2
Terminated NCT05056103 - Automated Secretion Removal in ICU Patients N/A
Active, not recruiting NCT04558476 - Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation Phase 2
Recruiting NCT05295186 - PAV Trial During SBT Trial
Active, not recruiting NCT05370248 - The Effect of 6 ml/kg vs 10 ml/kg Tidal Volume on Diaphragm Dysfunction in Critically Mechanically Ventilated Patient N/A
Completed NCT04589910 - Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound. N/A
Completed NCT04818164 - Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome
Completed NCT04193254 - LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
Not yet recruiting NCT03245684 - Assisted or Controlled Ventilation in Ards (Ascovent) N/A
Completed NCT06332768 - NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients N/A
Not yet recruiting NCT03259854 - Non Invasive Mechanical Ventilation VERSUS Oxygen MASK N/A