Design Requirements of Robotic Systems for Assisting Percutaneous Tracheostomy: A Scoping Review and Development Framework

Percutaneous dilatational tracheostomy (PDT) is a common procedure for patients managed in Intensive Care Units (ICUs). PDT has equivalent complication rates to surgical tracheostomy but can be performed at the ICU bedside, eliminating delays in the procedure. However, PDT complications associated with initial needle insertion into the trachea still exist and can cause severe consequences such as pneumothorax, major haemorrhage, and death. Robotic technology is a powerful adjunct to assist manual surgery, improving procedural safety and accuracy. Whilst robotic surgery of the airway has become established, there is limited research and guidance regarding robotics to assist tracheostomy insertions. This study aims to identify design requirements that map clinical needs to design details and motivate the development of a scientific design framework in robotic tracheostomy. A literature search in Google Scholar, PubMed, and Web of Science on topics relevant to robotic tracheostomy was conducted. Clinical requirements were evaluated by distributing an online questionnaire to professional clinicians. Thirteen eligible studies were presented, from which 36 design requirements in four categories were collected. We present a design framework to inform the development of robotic tracheostomy with key requirements validated for suitability by relevant healthcare professionals.