Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04668742
Status:
COMPLETED
Last Update Posted:
2022-04-06
First Post:
2020-11-23
Brief Title:
Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients
Sponsor:
Fundación Cardiovascular de Colombia
Organization:
Fundación Cardiovascular de Colombia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAtraq
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 001 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 Students 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
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 Students 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None