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Disturbance of AttentionNCT03363152

MinIAttention - Attention Management in Minimal Invasive Surgery

An observational study of Disturbance of Attention, run by Kepler University Hospital at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Laparoscopic surgical suboptimal outcomes in patient safety measures are correlated with (i) cognitive load / level of attention of the operating surgeon, (ii) the frequency and degree of disruptions to the surgical workflow, and (iii) the misalignment of visual and motor axes in laparoscopic equipment / setting… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Disturbance of Attention
How many people
42 participants
Where
1 siteAustria
Study dates
6 Jul 2016to 30 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: surgeons for General and Visceral surgery

Who may be able to join

  • laparoscopic cholecystectomy

Who cannot join

  • open surgical procedures

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Kepler university clinic

    Linz, Upper Austria, 4020

Other trials in Austria

About this study

Laparoscopic surgical suboptimal outcomes in patient safety measures are correlated with (i) cognitive load / level of attention of the operating surgeon, (ii) the frequency and degree of disruptions to the surgical workflow, and (iii) the misalignment of visual and motor axes in laparoscopic equipment / setting (eye-hand coordination).

Read the detailed description

Laparoscopic surgical suboptimal outcomes in patient safety measures are correlated with (i) cognitive load / level of attention of the operating surgeon, (ii) the frequency and degree of disruptions to the surgical workflow, and (iii) the misalignment of visual and motor axes in laparoscopic equipment / setting (eye-hand coordination).

This project will create the foundational, design and operational principles of future, surgeon-friendly minimal invasive surgery operating room information technologies (MIS-IT), which -given the ever growing complexity in surgical workflows, as well as instrument and equipment settings- will have to build on human attention as a scarce resource.

On the formal model's and methods' side, MinIAttention will identify types of human attention, as well as cognitive and physiological mechanisms revealing its relation to perception, memory, decision making, and learning. Starting with established theories of individual attention (Capacity Theory, Multiple Resource Theory, Feature Integration Theory) and the respective attention models (Broadbent, Kahneman, Wickens), the investigators will characterize aspects of attention of surgeons during MIS operations. MinIAttention will empirically evidence its models on the dynamics of a surgeon's attention along the workflow of a MIS operation. A multi-sensor attention recognition reference framework will be implementation, involving externalized signals of a surgeons attention (eye gaze, head and hand gesture, head and full body pose, physiological signals, as well as communication and social interaction). Evidenced MinIAttention attention models will represent the core body of aware surgeon assistance systems, covering (i) sensory assistance, enhancing the surgeons perceptual capacities, (ii) motor assistance, enhancing the surgeons motor and manipulative capacities (iii) decision making assistance, guiding the surgeon towards informed, evidence based, rational, transparent and timely decisions during operation, and (iv) cognitive assistance, enhancing the surgeons memory management capacities with background digital memory systems. On the purpose of supporting this research proposal with an early impression of the feasibility of the proposed research method and approach, the proposing partners have voluntarily set up prototypical attention capturing system. With this preliminary proposal support study the investigators have evidenced that ensembles of sensors together with our attention models can serve as a nonobtrusive, yet potentially effective means to determine indicators of a surgeon's attention during live surgeries. Above that, the pattern recognition methods an machine learning techniques appear viable for the task of automated attention and cognitive load diagnosis, and the proposed assistance and mulitmodal feedback system reveals feasible. The investigators can thus say, that the research method and approach which MinIAttention will build upon is solid, promising, and preliminarily evidenced beforehand.

Aside the MIS-IT focus of this project, MinIAttention will serve as a reference to a very general, observably upcoming information society dilemma: information overload and attention scarcity. In today's information-rich world, where people are overflooded with signals and messages at all levels of perception and modalities (visual, auditory, tactile, olfactory), the need to allocate attention efficiently among the overabundance of information sources appears to be among the most demanding challenges for ICT mediated communication today. For the design and implementation of novel, future ICT systems of all kinds, it is of high interest to understand how spontaneous, local, individual attention to novel information items occurs. Some two decades of HCI and pervasive/ubiquitous computing research have clearly revealed that out of the many indicative design factors for modern ICT, human attention is the first source of perception, consequently also awareness towards information and other individuals. MinIAttention will create the foundational basis for attention-aware ICT, i.e. develop (i) formal models of human attention along with (ii) multisensory recognition architectures and reasoning algorithms to estimate and assess levels of human attention, together with their (iii) embedding into ICT systems of everyday use.

Five international groups will collaborate to develop MinIAttention. JKU IPC has introduced attention aware ICT in the Pervasive Computing scientific community, developed pionieering methods and systems, and also promoted cognitive ICT to become a European research priority (H2020). AKH KUK runs Austrias most advanced laparoscopic operation theater with cutting edge technological equipment, Karl STORZ ENDOSKOPE is a worldwide leading surgical instrument supplier. SUSSEX is among the worlds most renowned institutions in machine learning related to wearable computing, as is FRI for vital state recognition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surgeon´s attention

    surgeon´s attention during laparoscopic surgery

    Measured: july 2017 until December 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2017
  2. Study start6 Jul 2016
  3. Primary completion30 Jan 2019
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03363152
Sponsor's protocol ID
Minatt-017
Status last verified
Oct 2023
First submitted
30 Nov 2017
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahmidi N, Hager GD, Ishii L, Fichtinger G, Gallia GL, Ishii M. Surgical task and skill classification from eye tracking and tool motion in minimally invasive surgery. Med Image Comput Comput Assist Interv. 2010;13(Pt 3):295-302. doi: 10.1007/978-3-642-15711-0_37.

    PubMed 20879412
  • Atkins MS, Tien G, Khan RS, Meneghetti A, Zheng B. What do surgeons see: capturing and synchronizing eye gaze for surgery applications. Surg Innov. 2013 Jun;20(3):241-8. doi: 10.1177/1553350612449075. Epub 2012 Jun 13.

    PubMed 22696024
  • Beatty J. Task-evoked pupillary responses, processing load, and the structure of processing resources. Psychol Bull. 1982 Mar;91(2):276-92. No abstract available.

    PubMed 7071262

Questions about this trial

What is this clinical trial studying?

An observational study of Disturbance of Attention, run by Kepler University Hospital at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

surgeon´s attention (time frame: july 2017 until December 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03363152, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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