Coronary Artery Disease Clinical Trial
— GAME-ONOfficial title:
Gauging Active Modalities of Error Detection and Signaling Obtained by Neural Interfaces in the Cathlab: The GAME-ON Study
Improvement of patients' care and outcome is largely based on development and validation of drugs and technologies, especially in rapidly evolving fields as Interventional Cardiology. In fact, even though the optimal efficiency of a cathlab can be influenced by Interventional Cardiologist's mental workload, stress' accumulation and performance, little if any attention is paid to the monitoring and optimization of his/her mental status. Electroencephalogram (EEG)-based neural-interfaces are able to estimate workload, fatigue and the degree of sleepiness through spectral analysis techniques. In particular, the amplitude of alpha waves is a widely validated indicator of mental engagement's level. Developing a low cost and highly feasible device to monitor and analyze operator's mental engagement level and performance could be extremely appealing, especially considering both the lack of data in literature for interventional disciplines and the recent technology developments.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - indication to coronary artery angiography and/or percutaneous coronary intervention Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Italy | University Hospital of Ferrara | Ferrara |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
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Morales JM, Ruiz-Rabelo JF, Diaz-Piedra C, Di Stasi LL. Detecting Mental Workload in Surgical Teams Using a Wearable Single-Channel Electroencephalographic Device. J Surg Educ. 2019 Jul-Aug;76(4):1107-1115. doi: 10.1016/j.jsurg.2019.01.005. Epub 2019 Jan — View Citation
Puma S, Matton N, Paubel PV, Raufaste E, El-Yagoubi R. Using theta and alpha band power to assess cognitive workload in multitasking environments. Int J Psychophysiol. 2018 Jan;123:111-120. doi: 10.1016/j.ijpsycho.2017.10.004. Epub 2017 Oct 7. — View Citation
Putilov AA, Donskaya OG. Alpha attenuation soon after closing the eyes as an objective indicator of sleepiness. Clin Exp Pharmacol Physiol. 2014 Dec;41(12):956-64. doi: 10.1111/1440-1681.12311. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleepiness Sensitivity KSS | Sensitivity: proportion of operators with positive AAC ratio (AAC ratio values above study population median value are considered associated with sleepiness) of positive KSS questionnaire ones (true positive). KSS is defined as positive for values above preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | |
Primary | Sleepiness Sensitivity SQS | Sensitivity: proportion of operators with positive AAC ratio of positive SQS questionnaire ones (true positive). SQS is defined as positive for values above preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | |
Primary | Sleepiness Specificity KSS | Specificity: proportion of operators with negative AAC ratio (AAC ratio values below study population median value are not considered associated with sleepiness) of negative KSS questionnaire ones (true negative). KSS is defined as negative for values below preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | |
Primary | Sleepiness Specificity SQS | Specificity: proportion of operators with negative AAC ratio (AAC ratio values below study population median value are not considered associated with sleepiness) of negative SQS questionnaire ones (true negative). SQS is defined as negative for values below preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | |
Primary | Fatigue Sensitivity POMS-F | Sensitivity: proportion of operators with positive AAC ec/eo/mean (AAC ec/eo/mean values above study population median value are considered associated with fatigue) of positive POMS-F questionnaire ones (true positive). POMS-F is defined as positive for values above preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | |
Primary | Fatigue Specificity POMS-F | Specificity: proportion of operators with negative AAC ec/eo/mean (AAC ec/eo/mean values below study population median value are not considered associated with fatigue) of negative POMS-F questionnaire ones (true negative). POMS-F is defined as negative for values below preliminary study population median value (two months sampling of the same population between February and March 2021). | pre-procedure | |
Primary | On task psycho-physical stress NASA-TLX | Proportion of operators with positive Alpha Prevalence (AP) eo (AP eo values above study population median value are considered associated with psychophysical stress) at the beginning of the procedure, end of the procedure and mean value during the procedure of operators with positive NASA-Task Load Index (TLX) (NASA-TLX value above preliminary study population median value (two months sampling of the same population between February and March 2021)). | intraprocedure | |
Primary | On task psycho-physical stress rMSSD | Proportion of operators with positive AP eo (AP eo values above study population median value are considered associated with psychophysical stress) at the beginning of the procedure, end of the procedure and mean value during the procedure of operators with positive rMSSD (rMSSD value below preliminary study individual's mean value). | intraprocedure | |
Primary | Correlation AP and rMSSD | Evaluate the correlation between AP and rMSSD curve during the procedure. Curves are built by evaluating AP and rMSSD values in 5 minutes slots all along the procedure. | intraprocedure | |
Secondary | AUC Fatigue POMS-F (positive) | Area under the curve (AUC) of AAC eo/ec/mean positive for POMS-F positive | pre-procedure | |
Secondary | AUC Sleepiness KSS/SQS | Area under the curve (AUC) of AAC ratio positive for KSS/SQS positive | pre-procedure | |
Secondary | Procedural lengthening | To discriminate whether positive AAC eo at the beginning of the procedure, at the end of the procedure and the mean value during the procedure is associated with longer procedure time, higher contrast volume and x-ray time after correction for confounders (clinical presentation, number of treated vessels, calcifications, etc.) | intraprocedure |
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