TY - JOUR
T1 - Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device
AU - Orozco-Levi, Mauricio
AU - Reyes, Carlos
AU - Quintero, Neikel
AU - Tiga-Loza, Diana
AU - Reyes, Mabel
AU - Sanabria, Sandra
AU - Pizarro, Camilo
AU - De Hoyos, Juan
AU - Serrano, Norma
AU - Castillo, Victor
AU - Ramírez-Sarmiento, Alba
N1 - Publisher Copyright:
© 2022 Orozco-Levi et al.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Introduction: 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.
AB - Introduction: 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.
KW - alignment
KW - DYNAtraq
KW - mechanical ventilation
KW - tracheostomy
KW - tubes
UR - http://www.scopus.com/inward/record.url?scp=85134167200&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/60b6f646-9a67-38c0-ae72-3ec70903064c/
U2 - 10.2147/MDER.S366829
DO - 10.2147/MDER.S366829
M3 - Artículo Científico
AN - SCOPUS:85134167200
SN - 1179-1470
VL - 15
SP - 215
EP - 227
JO - Medical Devices: Evidence and Research
JF - Medical Devices: Evidence and Research
ER -