Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

Not Applicable

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Other: ProbeFix; Other: Manual hold

• Registration Number: NCT04016363
• Lead Sponsor: Amir Abbas Mahabadi

Brief Summary

Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-11
• Study Start: 2020-01-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing clinically indicated pharmacological stress-echocardiography
• Willingness to participate

Exclusion Criteria

• Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
• poor image quality
• Early termination of the stress-echocardiography examination for clinical reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProbeFix arm	ProbeFix	The echocardiography probe is fixated on the patient's thorax using the ProbeFix
Controll arm	Manual hold	The sonographer manually holds the probe on the patient's thorax

Primary Outcome Measures

Name	Time	Method
Duration of stress-echocardiography examination	During the examination	Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion

Secondary Outcome Measures

Name	Time	Method
Echocardiography axis deviation in 4 chamber view	During the examination	In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany