Increasing the precision of simulated percutaneous dilatational tracheostomy-a pilot prototype device development...

Area of Science:

• Medical Devices
• Surgical Innovation
• Airway Management

Background:

• Percutaneous dilatational tracheostomy (PDT) is a critical bedside procedure for airway access.
• Needle misplacement during PDT occurs in approximately 5% of cases, leading to significant patient harm.
• Improving the precision of initial needle insertion is crucial for patient safety and procedural success.

Purpose of the Study:

• To develop and evaluate a prototype medical device, the Guidance for Tracheostomy (GiFT) system.
• To enhance the accuracy of initial needle insertion during percutaneous dilatational tracheostomy.
• To assess the potential of GiFT to reduce PDT-related complications.

Main Methods:

• Development of the GiFT system, which provides real-time feedback on needle and target sensor locations.
• Testing the GiFT system in simulated "difficult neck" models with both untrained and experienced medical personnel.
• Comparative analysis of accuracy and time-to-target between guided (GiFT) and unguided PDT needle insertions.

Main Results:

• The GiFT system significantly improved needle insertion accuracy compared to unguided attempts (mean difference 10.0 mm, p < 0.001).
• While the GiFT system increased time-to-target (mean difference 56.1 s, p < 0.001), this increase was deemed clinically insignificant.
• Both untrained and experienced participants demonstrated improved accuracy with the GiFT system.

Conclusions:

• The GiFT system shows significant potential as a proof-of-concept to enhance PDT needle placement precision.
• Improved accuracy with GiFT can lead to reduced procedural complications and improved patient outcomes.
• The GiFT system may enable wider application of bedside PDT, benefiting more patients.