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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20795

Enrollment

Registered

2019-07-08

Start date

2019-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 ha

Eligibility

Inclusion criteria

Inclusion criteria: Elective procedures, Procedures with repetitive actions, in this study limited to: - diagnostic laparoscopy - laparoscopic lymph node resection - laparoscopic appendectomy - laparoscopic cholecystectomy - laparoscopic Heller myotomy - laparoscopic hernia diaphragmatica repair - laparoscopic fundoplication - laparoscopic stoma formation - laparoscopic oesophageal surgery - laparoscopic adrenal gland surgery Procedures performed on patients aged >18 years Informed consent of the patient to be operated on in a medical data recorder augmented OR

Exclusion criteria

Exclusion criteria: Emergency Surgery, Absence of a circulation nurse, Surgerin In OR's other than OR 20 in the Amsterdam UMC, location AMC

Design outcomes

Primary

Measure	Time frame
Quantification of disruptions of workflow using the MDR in both the intervention and control group	—

Secondary

Measure	Time frame
- Comparing the quantified delay between a command and complete execution of the command in both intervention groups and the control group as detected in a MDR augmented OR - Comparing the error rate of the execution of a command when using direct human-computer interaction using inertial wearable sensors with the error rate in the control group as objectified in a medical data recorder augmented OR. An error is defined as the incorrect execution of a command, execution of the wrong command (misinterpretation), or incapability to execute the command (lack of proficiency in using the equipment). - Assessing the self-reported frustration on a three-item frustration scale, comparing frustration between both intervention groups and control group and correlate frustration to the number of reported errors, the delay and the number of disruptions of workflow. - Assessment of changes in communication in relation to the disruptions of workflow, quantified delay and error rates. - Assessment of NASA TLX scores, comparing intervention and control group and correlation with the number of reported errors, delay and the number of disruptions of workflow - Assessment of body metrics (HR, HRV and RPM) in the Myo™ Armband, Plantronics headset and control group, comparison between intervention and control group and correlation with reported frustration and reported NASA TLX scores. - Evaluation of satisfaction with the use of the TedCube© system and associated sensors or third person interaction using a self-developed questionnaire.	—

Measure

Time frame

- Comparing the quantified delay between a command and complete execution of the command in both intervention groups and the control group as detected in a MDR augmented OR - Comparing the error rate of the execution of a command when using direct human-computer interaction using inertial wearable sensors with the error rate in the control group as objectified in a medical data recorder augmented OR. An error is defined as the incorrect execution of a command, execution of the wrong command (misinterpretation), or incapability to execute the command (lack of proficiency in using the equipment). - Assessing the self-reported frustration on a three-item frustration scale, comparing frustration between both intervention groups and control group and correlate frustration to the number of reported errors, the delay and the number of disruptions of workflow. - Assessment of changes in communication in relation to the disruptions of workflow, quantified delay and error rates. - Assessment of NASA TLX scores, comparing intervention and control group and correlation with the number of reported errors, delay and the number of disruptions of workflow - Assessment of body metrics (HR, HRV and RPM) in the Myo™ Armband, Plantronics headset and control group, comparison between intervention and control group and correlation with reported frustration and reported NASA TLX scores. - Evaluation of satisfaction with the use of the TedCube© system and associated sensors or third person interaction using a self-developed questionnaire.

—

Contacts

Public ContactMarilou Jansen

Amsterdam UMC, location AMC

m.jansen@amsterdamumc.nl0200563370

Outcome results