NCT03927755

Brief Summary

The goal of this study is to measure the hypothetical minimal amount of time it takes to perform a single view bedside trans-thoracic echo (TTE) comparing sub-xyphoid view and the parasternal long view. Physicians will be timed from initiation of imaging to completion of the recording of a single view of the heart. Images will be rated for quality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

7 months

First QC Date

April 22, 2019

Last Update Submit

April 15, 2020

Conditions

Keywords

Bedside Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Timing of Ultrasound Imaging

    Number of seconds from start to finish of the ultrasound imaging

    10 seconds

Secondary Outcomes (1)

  • Quality of Ultrasound Imaging

    5 seconds

Study Arms (2)

Sub-xyphoid

Ultrasound views of the heart obtained using the sub-typhoid approach. Individuals with a mix of co-morbidities but are clinically stable will be viewed. Physicians with experience in bedside ultrasound are being studied.

Other: Education

Para-sternal Long

Ultrasound views of the heart obtained using the parasternal long approach. Individuals with a mix of co-morbidities but are clinically stable will be viewed. Physicians with experience in bedside ultrasound are being studied.

Other: Education

Interventions

Physicians will undergo training on how to rapidly obtain appropriate images.

Para-sternal LongSub-xyphoid

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All physicians participating in existing ultrasound educational programs will be considered for enrollment.

You may qualify if:

  • Physicians with experience in bedside cardiac ultrasound

You may not qualify if:

  • Unwilling to consent to study
  • Appropriate ultrasound equipment not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMASS Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (6)

  • Yu T, Weil MH, Tang W, Sun S, Klouche K, Povoas H, Bisera J. Adverse outcomes of interrupted precordial compression during automated defibrillation. Circulation. 2002 Jul 16;106(3):368-72. doi: 10.1161/01.cir.0000021429.22005.2e.

    PMID: 12119255BACKGROUND
  • Steen S, Liao Q, Pierre L, Paskevicius A, Sjoberg T. The critical importance of minimal delay between chest compressions and subsequent defibrillation: a haemodynamic explanation. Resuscitation. 2003 Sep;58(3):249-58. doi: 10.1016/s0300-9572(03)00265-x.

    PMID: 12969599BACKGROUND
  • Vaillancourt C, Everson-Stewart S, Christenson J, Andrusiek D, Powell J, Nichol G, Cheskes S, Aufderheide TP, Berg R, Stiell IG; Resuscitation Outcomes Consortium Investigators. The impact of increased chest compression fraction on return of spontaneous circulation for out-of-hospital cardiac arrest patients not in ventricular fibrillation. Resuscitation. 2011 Dec;82(12):1501-7. doi: 10.1016/j.resuscitation.2011.07.011. Epub 2011 Jul 18.

    PMID: 21763252BACKGROUND
  • Clattenburg EJ, Wroe P, Brown S, Gardner K, Losonczy L, Singh A, Nagdev A. Point-of-care ultrasound use in patients with cardiac arrest is associated prolonged cardiopulmonary resuscitation pauses: A prospective cohort study. Resuscitation. 2018 Jan;122:65-68. doi: 10.1016/j.resuscitation.2017.11.056. Epub 2017 Nov 23.

    PMID: 29175356BACKGROUND
  • Huis In 't Veld MA, Allison MG, Bostick DS, Fisher KR, Goloubeva OG, Witting MD, Winters ME. Ultrasound use during cardiopulmonary resuscitation is associated with delays in chest compressions. Resuscitation. 2017 Oct;119:95-98. doi: 10.1016/j.resuscitation.2017.07.021. Epub 2017 Jul 25.

    PMID: 28754527BACKGROUND
  • Zhan L, Yang LJ, Huang Y, He Q, Liu GJ. Continuous chest compression versus interrupted chest compression for cardiopulmonary resuscitation of non-asphyxial out-of-hospital cardiac arrest. Cochrane Database Syst Rev. 2017 Mar 27;3(3):CD010134. doi: 10.1002/14651858.CD010134.pub2.

    PMID: 28349529BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Romolo Gaspari, MD. PhD

    UMASS Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Emergency Medicine

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 25, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 2, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Results will be presented at scientific meetings and published in peer reviewed publications.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
available after completion of statistical review and write up of results.
Access Criteria
Freely available to whomever requests.

Locations