Evaluation of the LVivo Image Quality Scoring (IQS)

NCT05563701 | Completed

• 1 other identifier: CR2P0021
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The study includes two parts: Part 1:

• 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively. Each study includes 10 clips that represent typical user scanning errors
• Offline evaluation of the system (by batch processing) shall be performed by comparing the system output to preliminary quality tagging by experienced sonographers Part 2:
• Live scans of apical 4CH clips of patients with indication for POCUS examination will be performed by POC physicians
• LVivo IQS shall be used (on Lumify) during the scan for patients that meet inclusion criteria until 50 exams will be collected. 3 sec of each scan shall be saved, and Image quality score (IQS) shall be documented
• Saved scans shall be reviewed by an expert physician to determine whether they are clinically interpretable

Conditions

Heart Diseases; Arrhythmia, Cardiac; Angina Pectoris; Unstable Angina; Lung Diseases; Congestive Heart Failure; Shock

Keywords

Echocardiography (Echo); Image Quality Scoring (IQS); Ultrasound (US); Point of Care (POC); 4CH (Four (4) Chamber of the heart view); LV (Left Ventricle); ER (Emergency Room); ICU (Intensive Care Unit); EF (Ejection Fraction)

Outcome Measures

Primary Outcomes (3)

• Part 1: Overall agreement of 75% between image quality classification by LVivo IQS and the data tagging by experienced sonographers

  Up to 24 weeks

• Part 2: 80% of the Exams with image quality 3-5 by visual estimation, received at least "Medium" image quality by LVivo IQS

  Up to 24 weeks

• Part 2: 90% of these cases (when at least "Medium" image quality is indicated by LVivo IQS) are clinically interpretable

  Up to 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Part 1 Patients age ≥18 referred for echo evaluation Part 2 Patients age ≥18 with indication for POCUS examination

You may qualify if:

• Part 1 Study:
• Age ≥18
• Referred to routine Echo examination
• Part 2 Study:
• Age ≥18
• Indication for POCUS

You may not qualify if:

• Part 1 Study:
• Part 2 Study:
• Image quality 1-2 according to ACEP June 2018 \[11\]

Sponsors & Collaborators

• DiA Imaging Analysis Ltd: lead

Study Sites (1)

Soroka university medical center

Beersheba, Israel

Location

Related Publications (13)

• Johri AM, Galen B, Kirkpatrick JN, Lanspa M, Mulvagh S, Thamman R. ASE Statement on Point-of-Care Ultrasound during the 2019 Novel Coronavirus Pandemic. J Am Soc Echocardiogr. 2020 Jun;33(6):670-673. doi: 10.1016/j.echo.2020.04.017. Epub 2020 Apr 15.

  PMID: 32503704 BACKGROUND

• Hashim A, Tahir MJ, Ullah I, Asghar MS, Siddiqi H, Yousaf Z. The utility of point of care ultrasonography (POCUS). Ann Med Surg (Lond). 2021 Nov 2;71:102982. doi: 10.1016/j.amsu.2021.102982. eCollection 2021 Nov. No abstract available.

  PMID: 34840746 BACKGROUND

• Dall T. et al. The Complexities of Physician Supply and Demand: Projections From 2019 to 2034. Association Of American Medical Collage, 2021.

  BACKGROUND

• Blanco P, Volpicelli G. Common pitfalls in point-of-care ultrasound: a practical guide for emergency and critical care physicians. Crit Ultrasound J. 2016 Dec;8(1):15. doi: 10.1186/s13089-016-0052-x. Epub 2016 Oct 26.

  PMID: 27783380 BACKGROUND

• Smistad E, Ostvik A, Salte IM, Melichova D, Nguyen TM, Haugaa K, Brunvand H, Edvardsen T, Leclerc S, Bernard O, Grenne B, Lovstakken L. Real-Time Automatic Ejection Fraction and Foreshortening Detection Using Deep Learning. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Dec;67(12):2595-2604. doi: 10.1109/TUFFC.2020.2981037. Epub 2020 Nov 24.

  PMID: 32175861 BACKGROUND

• Unlu S, Duchenne J, Mirea O, Pagourelias ED, Bezy S, Cvijic M, Beela AS, Thomas JD, Badano LP, Voigt JU; EACVI-ASE Industry Standardization Task Force. Impact of apical foreshortening on deformation measurements: a report from the EACVI-ASE Strain Standardization Task Force. Eur Heart J Cardiovasc Imaging. 2020 Mar 1;21(3):337-343. doi: 10.1093/ehjci/jez189.

  PMID: 31361311 BACKGROUND

• Kumar V. There is No Substitute for Human Intelligence. Indian J Crit Care Med. 2021 May;25(5):486-488. doi: 10.5005/jp-journals-10071-23832.

  PMID: 34177163 BACKGROUND

• Narang A, Bae R, Hong H, Thomas Y, Surette S, Cadieu C, Chaudhry A, Martin RP, McCarthy PM, Rubenson DS, Goldstein S, Little SH, Lang RM, Weissman NJ, Thomas JD. Utility of a Deep-Learning Algorithm to Guide Novices to Acquire Echocardiograms for Limited Diagnostic Use. JAMA Cardiol. 2021 Jun 1;6(6):624-632. doi: 10.1001/jamacardio.2021.0185.

  PMID: 33599681 BACKGROUND

• Liu B.R et al. Emergency Ultrasound Standard Reporting Guidelines. ACEP, 2018. pp. 2-44.

  BACKGROUND

• Dixon, W.J., Massey, F.J. Introduction to Statistical Analysis. 4th Edition McGraw-Hill, 1983. pp. 105-107

  BACKGROUND

• Nagata Y, Kado Y, Onoue T, Otani K, Nakazono A, Otsuji Y, Takeuchi M. Impact of image quality on reliability of the measurements of left ventricular systolic function and global longitudinal strain in 2D echocardiography. Echo Res Pract. 2018 Mar;5(1):27-39. doi: 10.1530/ERP-17-0047. Epub 2018 Feb 5.

  PMID: 29432198 BACKGROUND

• Russell FM, Herbert A, Ferre RM, Zakeri B, Echeverria V, Peterson D, Wallach P. Development and implementation of a point of care ultrasound curriculum at a multi-site institution. Ultrasound J. 2021 Feb 21;13(1):9. doi: 10.1186/s13089-021-00214-w.

  PMID: 33615390 BACKGROUND

• Goldman, L. et al. Echocardiography. Elsevier, Inc, 2020. pp. 253-260

  BACKGROUND

Related Links

• EchoNous official cite
• Ultrasight official site

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac; Angina Pectoris; Angina, Unstable; Lung Diseases; Heart Failure; Shock; Emergencies

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Diseases; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 3, 2022
• Study Start: September 5, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)