Using the best wearable sensor in facilitating hands-free, sterile control in the operating room

Rationale: Interaction with electronically controlled operating room (OR) systems embedded in modern surgical environments such as the ‘STORZ OR 1’ and ‘Olympus ENDOALPHA’ is everyday practice for surgeons performing Minimally Invasive Surgery (MIS) in our hospital. While there is a non-sterile operating nurse available in the OR, capable of interacting with these systems upon request by the surgeon, this indirect control is mostly slow, prone for error and disrupting surgical workflow. Facing an unanticipated and unwanted outcome may result in frustration and eventually even anger, both examples of distress emotions. Distress emotions are undesirable when performing surgery, since they may impact available cognitive workload. Furthermore, they may result in negative communication, hampering OR-team empowerment and effective leadership. Both factors are known to negatively influence quality and safety in the OR.
The TedCube© system is a plug and play device enabling wearable sensors to act as a wireless alternative for a regular computer mouse, therefore enabling direct hands-free and sterile control of the OR.
Objective: The aim of the TedTrial is to investigate what setup best enables surgeons to interact with the endoscopic operation room setup during surgical procedures. As a result, delays, errors and disruptions of workflow may be reduced. Outcome parameters are time from a command until complete execution of said command, number of delays, number of workflow disruptions, OR communication, distress and satisfaction. Outcome parameters will be objectified using medical data recorder (MDR) derived output. Distress will be objectified using both biometric analysis and questionnaires. Satisfaction with the hands-free system will be evaluated using a questionnaire.
Study design: This study is an observational trial with three different arms: Intervention group 1) direct interaction by surgeon with OR environment using TedCube© and Myo™ armband, Intervention group 2) direct interaction of surgeon with OR environment using Tedcube© and Plantronics© wireless microphone headset. The third arm is the control group using indirect interaction of surgeon with OR environment using third-person computer interaction. All study procedures will be performed in a MDR augmented OR, in order to objectify communication patterns, workflow disruptions, errors and delays. Surgeons in both intervention groups and the control group will wear a special t-shirt equipped with multiple sensors registering biometric parameters to objectify symptoms of distress (frustration and anger). All surgeons will be asked to complete a questionnaire post-operatively about experienced levels of frustration. In parallel, any system failure or not-executed command during control-procedures is registered. Satisfaction with the way of interaction is evaluated with a questionnaire after each surgical procedure. Subjectively reported parameters on frustration are compared between groups and correlated to objectively measured biometric parameters. Satisfaction is evaluated using a self-developed questionnaire and correlated with errors occurring during surgery.
Study population: The study population consists of volunteering gastro-intestinal MIS surgeons, since anticipated interaction with the ENDOALPHA operating system is the highest in procedures performed in this subspecialty.
Intervention: The TedCube© will be set-up prior to every surgical procedure by researcher. No software needs to be installed on the hospital computer for the system to work, as it is a ‘plug&play’ device. The TedCube© simulates a remote controlled USB-mouse or -keyboard, and has the same technical functionalities as a normal computer mouse, except the input may come from wearable sensors such as armbands or microphones. TedCube© has already been tested for integration in the Olympus ENDOALPHA operating rooms and has shown to be both feasible and reliable, not breeching computer software nor AMC data protocol (pilot feasibility test).
Main study parameters/endpoints: Main endpoint of study is the number of workflow disruptions due to the operation of laparoscopic OR equipment. Secondary endpoints are error rate, delay, team communication, subjectively reported frustration and satisfaction with the system and objectively measured stress as symptom of frustration and anger as distress emotions.
Results: Primary and secondary endpoints of study are compared among groups. It is anticipated that reduction of miscommunication, error and delay may result in a reduction of distress emotions.

OR workflow for surgeons needing to interact with the laparoscopic equipment during surgery is optimized using TedCube© in combination with the Myo™ gesture control armband and/or a wireless headset.

05-07-2019: approval METC
01-08-2019: start first inclusion
31-12-2019: study closed

The TedCube© (TedCas Systems S.L., Navarra, Spain) enables touchless interaction with any PC or computer system that can be controlled using USB-mouse and keyboard input. In this case, allowing for hands-free and sterile interaction with the Olympus ENDOALPHA panel.
This study has three arms. Intervention arm 1 uses the TedCube sysem in combination with the plantronics headset to enable hands-free interaction using voice control, Intervention arm 2 uses the TedCube system in combination with Myo armband using gesture control. The third arm is the control group using third person interaction.