heart defects heart diseases cardiac pathologies
Conditions
Interventions
The BBE is a robot that performs automated TTEs. The BBE consists of a bed whereunder a robot arm with an ultrasound probe is mounted. The robot arm moves the ultrasound probe over the patient's body
Sponsors
Corbotics B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Listed to undergo a standard TTE - Age >= 18 years
Exclusion criteria
Exclusion criteria: • patients who are unable to lie in a prone position (unable to lay in the positions required for complete TTE and BBE exams)• patients with a weight >200 kg • patients with breast amputation or implants in the left breast • patients with known congenital heart disease • patients suffering from pectus excavatum/carinatum • patients with injuries on the torso that would hinder examination • unable to sign or understand informed consent • patients who are already known not to be accessible to echocardiography (i.e., very poor quality TTE images) • patients who are scheduled for a TTE with baseline criteria and application form that require clips not listed in Table 1 of the research protocol (i.e. baseline criteria where suprasternal clips are required to be clinically usable)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the percentage of clinically usable autonomous TTEs in patients with clinically usable manual TTEs using the same ultrasound system, where clinically usable is defined as reaching Likert Scores 3 and higher in a 5-point Likert scale. Autonomous and manual TTEs of each participant will together be randomly assigned to two of ten independent EACVI certified evaluators who will review the clinical usability based on the baseline criteria and application form as presented to the judging cardiologists. This could be, for example, shortness of breath or a murmur. They will assign 1 to 5 points to each TTE, 1 point reflecting a very poor quality, and 5 points reflecting an excellent quality (a 5-points Likert scale, see also Appendix 1). If an TTE is rated 3 points or more, the TTE is qualified as 'sufficient for diagnostics'. If the two evaluators disagree on whether or not the TTE is sufficient for diagnosis, a third evaluator will give the deciding vote. The clinical usability of the clips is rated considering the specifications of the ultrasound system integrated in the BBE. The evaluators will be introduced to the specifications of the ultrasound system prior to TTE evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint of the study is the difference in Likert scale ratings per clip between the autonomous and manual clips. The clips will be randomly and equally assigned to one of ten independent EACVI evaluators who will review the quality. They will assign 1 to 5 points to each clip, 1 point reflecting a very poor quality, and 5 points reflecting an excellent quality (a 5-points Likert scale). If a clip is rated 3 points or more, it is qualified as *clinically usable*. This will result in a separate success rates per clip in Table 1Table 1, both for the autonomously acquired clips, as well as for the manually acquired clips. The Likert scale ratings will be supported by a quantitative comparison using the results from measurements done on both the manual and autonomously acquired clips during phase 2. These quantitative results will be compared to highlight differences between manual and autonomous clips in the measurements resulting from the TTE, which might in a clinical setting also be used to perform diagnosis. | — |
Countries
Netherlands
Contacts
Public ContactS.D. Bonhof-Minnaar
Corbotics B.V.
Outcome results
None listed