Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device

Abstract

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.

Keywords:

• mechanical ventilation
• tracheostomy
• DYNAtraq
• alignment
• tubes

Data Sharing Statement

The authors intend to share with other individuals unidentified participant data including demographics, clinical characteristics, and specific data regarding safety and efficacy of the device. Data is available on request from the corresponding author ([email protected]).

Acknowledgments

We thank Mayerly Martínez for her assistance in acquisition of data. This study was supported in part by MINCIENCIAS (COLCIENCIAS) Ref. 656677758319, CT-670-2018 and Fundación Cardiovascular de Colombia.

Disclosure

The authors MOL, CR and ARS declare to be the inventors with intellectual property of the device. The patrimonial property of the device belongs to the FCV institution. MOL reports grants from the Ministry of Science and Technology of Colombia MINCIENCIAS, during the conduct of the study, and has patent licensed to ref NC2016/0002057. The authors report no other potential conflicts of interest for this work.