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

Sponsor
Amir Abbas Mahabadi (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04016363
Collaborator
(none)
0
1
2
12
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ProbeFix
  • Other: Manual hold
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ProbeFix arm

The echocardiography probe is fixated on the patient's thorax using the ProbeFix

Other: ProbeFix
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Active Comparator: Controll arm

The sonographer manually holds the probe on the patient's thorax

Other: Manual hold
ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Other Outcome Measures

  1. Cost-effectiveness [During the examination]

    Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Essen Essen NRW Germany 45147

Sponsors and Collaborators

  • Amir Abbas Mahabadi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amir Abbas Mahabadi, Principal Investigator, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT04016363
Other Study ID Numbers:
  • 19-TEMP815870-BO
First Posted:
Jul 11, 2019
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2021