A Tracheostomy Support Device to Reduce Tracheostomy-Related Pressure Injury.

BACKGROUND: Tracheostomies provide many advantages for the care of patients who are critically ill but may also result in complications, including tracheostomy-related pressure injuries. Research efforts into the prevention of these pressure injuries has resulted in specialized clinical care teams and pathways. These solutions are expensive and labor intensive, and fail to target the root cause of these injuries; namely, pressure at the device-skin interface. Here we measure that pressure directly and introduce a medical device, the tracheostomy support system, to reduce it. METHODS: This was a cross-sectional study of 21 subjects in the ICU, each with a tracheostomy tube connected to a ventilator. A force-sensing resistor was used to measure baseline pressures at the device-skin interface along the inferior flange. This pressure was then measured again with the use of the tracheostomy support system in the inactive and active states. Resultant pressures and demographics were compared. RESULTS: Fifteen male and 6 female subjects, with an average age of 47 ± 14 (mean ± SD) years, were included in this study. Average pressures at the tracheostomy-skin interface at baseline in these 21 ICU subjects were 273 ± 115 (mean ± SD) mm Hg. Average pressures were reduced by 59% (median 62%, maximum 98%) with the active tracheostomy support system to 115 ± 83 mm Hg (P < .001). All the subjects tolerated the tracheostomy support system without issue. CONCLUSIONS: Despite best clinical practice, pressure at the tracheostomy-skin interface can remain quite high. Here we provide measures of this pressure directly and show that a tracheostomy support system can be effective at minimizing that pressure.

Endotracheal tube forces exerted on the larynx and a novel support device to reduce it.

Objective: Endotracheal tubes (ETTs) are commonly associated with laryngeal injury that may be short lasting and temporary or more severe and life altering. Injury is believed to result from forces that these ETTs exert on the larynx. Here we quantify the forces of ETTs of various sizes on the laryngotracheal complex to gain a more quantitative understanding of these potential damaging forces. Here we also perform preclinical testing of a novel support device to offload these forces. Methods: Endotracheal intubation was performed on a fresh human cadaver using various ETT sizes. A strain-sensitive graphene nanosheet sensor and a commercially available force sensing resistor were secured behind the larynx, anterior to the prevertebral fascia. The forces exerted on the larynx were measured for each of the commonly used ETTs. A novel support device, ETT clip (Endo Clip), was attached to the ETTs and changes in these forces were observed. Results: Forces exerted on the laryngotracheal complex by various ETTs were observed to increase with increasing tube size. This pressure can be significantly reduced with a novel ETT clip. Conclusion: Here we demonstrate the first quantitative measurement of forces that ETTs exert on the larynx. We demonstrate a novel device that can easily clip onto an ETT reducing pressure on the laryngotracheal complex. This preclinical test paves the way for a human clinical trial. Level of evidence: 5.