Medical Devices: Evidence and Research (Jul 2022)
Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device
Abstract
Mauricio Orozco-Levi,1– 3 Carlos Reyes,4 Neikel Quintero,1 Diana Tiga-Loza,1– 3 Mabel Reyes,1– 3 Sandra Sanabria,5 Camilo Pizarro,4 Juan De Hoyos,5 Norma Serrano,6 Victor Castillo,5,7 Alba Ramírez-Sarmiento1– 3,6 1Respiratory Department, Hospital Internacional de Colombia, Fundación Cardiovascular de Colombia (FCV), Floridablanca, Santander, Colombia; 2Group of Research in Muscle, Training and Lung Diseases (EMICON), Ministerio de Ciencia y Tecnología (MINCIENCIAS), Bogotá, Cundinamarca, Colombia; 3Department of Medicine, and Facultad de Ciencias Médicas y de la Salud, Universidad de Santander (UDES), Bucaramanga, Santander, Colombia; 4Department of Critical Care, Hospital Internacional de Colombia, Fundación Cardiovascular de Colombia (FCV), Floridablanca, Santander, Colombia; 5Bioengineering Research Group, Fundación Cardiovascular de Colombia (FCV), Floridablanca, Santander, Colombia; 6Research Center, Fundación Cardiovascular de Colombia (FCV), Floridablanca, Santander, Colombia; 7CEO, Fundación Cardiovascular de Colombia (FCV), Floridablanca, Santander, ColombiaCorrespondence: Mauricio Orozco-Levi, Respiratory Department, Hospital Internacional de Colombia, Fundación Cardiovascular de Colombia, Calle 155A no. 23-58, El Bosque, Floridablanca, Santander, Colombia, Tel +57 3175741421, Email [email protected]: Tracheostomy is one of the most common surgical strategies in intensive care units (ICU) and provides relevant clinical benefit for multiple indications. However, the complications associated with its use range from 5 to 40% according to different series. The risk of these complications could be reduced if fixation strategies and alignment of the tracheostomy tube with respect to the tracheal axis are improved.Aim: To build a functional device of technological innovation in respiratory medicine for the fixation and alignment of tracheostomy cannula (acronym DYNAtraq) and to evaluate its feasibility and safety in a pilot study in mechanically ventilated patients.Methods: Study carried out in four phases: (1) design engineering and functional prototyping of the device; (2) study of cytotoxicity and tolerance to the force of traction and push; (3) pilot study of feasibility and safety of its use in tracheostomized and mechanically ventilated patients; and (4) health workers satisfaction study.Results: The design of the innovative DYNAtraq device included, on the one hand, a connector with very little additional dead space to be inserted between the cannula and the ventilation tubes, and, on the other hand, a shaft with two supports for adhesion to the skin of the thorax with very high tolerance (several kilograms) to pull and push. In patients, the device corrected the malpositioned tracheostomy tubes for the latero-lateral (p < 0.001) and cephalo-caudal angles (p < 0.001). Its effect was maintained throughout the follow-up time (p < 0.001). The use of DYNAtraq did not induce serious adverse events and showed a 70% protective effect for complications (RR = 0.3, p < 0.001) in patients.Conclusion: DYNAtraq is a new device for respiratory medicine that allows the stabilization, alignment and fixation of tracheostomy tubes in mechanically ventilated patients. Its use provides additional benefits to traditional forms of support as it corrects misalignment and increases tolerance to habitual or forced movements. DYNAtraq is a safe element and can reduce the complications of tracheostomy tubes.Keywords: mechanical ventilation, tracheostomy, DYNAtraq, alignment, tubes
