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CompletedNCT03927755REASON-2Updated Apr 16, 2020

Timing For Single View Bedside Cardiac Ultrasound

An observational study in Echocardiography, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-04-16.

Sponsored by University of Massachusetts, Worcester · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Sex
All
01

Study 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.

Read the detailed description

This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Residents will be enrolled when performing ultrasound imaging on non-critically ill patients in the emergency department. Residents obtaining cardiac ultrasound images on patients in the emergency department during pre-planned educational sessions will be enrolled in a prospective manner.

Physicians participating in this study will undergo a short educational session on both techniques of cardiac ultrasound as well as rationale for performing cardiac ultrasound rapidly during cardiac arrest. This educational intervention will provide the cognitive framework for the physicians to participate in the study. Physicians will be told to obtain the images as fast as possible and to get good quality images but they will be able to stop imaging if they are unable to obtain the images rapidly.

Individual physicians will be randomized to obtain a single parasternal or sub-xyphoid view of the hear first, followed by the other view. TTE will be performed on conscious and awake patients in the emergency department. Imaging will be performed in front of research staff. Primary outcome is time from transducer-skin contact to completion of the digital recording of a visible heart beating. Secondary outcome is the quality of the ultrasound image using a 5-point image quality scale.

Patients who will be imaged in this study will be those patients that would have been imaged during the existing educational session (scan shift). The patient will not need consent but can be told about the study if needed. No patient will be imaged if they have the possibility of having a clinical deterioration during the ultrasound imaging. Each set of images (PSL and SX) will be from a unique patient.

Subject data, with Protected Health Information (PHI) removed, will be recorded on data sheets prior to uploading into a centralized electronic database as soon as possible. Data will be obtained during the educational encounter including: Resident ID, post graduate year (PGY) level, Number of Cardiac Ultrasounds performed prior to starting study, US view attempted first, Imaging duration (seconds), Patient height, weight gender and age.

The imaging protocol will be standardized for consistency of timing. Prior to the ultrasound imaging the patient and ultrasound machine will be positioned with the patient laying flat on their back with the ultrasound machine immediately next to the patient's stretcher. A numbered study identification number (ID) will be entered into the US machine instead of any actual patient identifiers. The patient will have the area of their chest and abdomen exposed where imaging will occur. No instructions will be given to the patient about the imaging other that to lay still and lay flat. The patient will not be told to take a deep breath or to hold their breath or to position themselves in any way. The study subject (i.e. physician) will stand to the left or right of the patient with the transducer in hand.

Imaging will commence when directed by research staff. The study subject (i.e. physician) is instructed to obtain a specific view of the heart as rapidly as possible, with an end goal of obtaining a clear view of the heart as it contracts. The study subject is instructed to balance speed and imaging quality, but the predominant instruction is to get it a view of the heart beating as quickly as possible. The study subject will record a 4 second digital clip of the heart and remove the transducer from the patient's skin when they are done. Upon completing the imaging of the first view the images will be scored and the subject will prepare to be timed on the second view.

The study subject (i.e. the physician) will be randomized to initially one of two views, PSL or SX. Ultrasound images will consist of a single recorded view, either subxyphoid or parasternal. The randomization will occur immediately prior to obtaining the images. Randomization will occur using binary randomization app on smart phone and this will be recorded on study sheet. The second view (whichever view was not done the first time) will be recorded immediately after the completion and recording of data from the first view.

TIMING OF CARDIAC IMAGES Timing will occur using a standardized protocol. The subject will be told to start their imaging at the direction of research staff. The timing will start when the ultrasound transducer touches the patients skin.The timing will end when the transducer is removed from the patients skin for the last time.

INTERPRETATION OF CARDIAC IMAGES Images will be rated for quality by both the subject and research staff immediately after image review. This will occur blinded to each other's rating. All ultrasound images will be recorded for later review. Ultrasound images will be rated using a 5 point imaging scale. Images will be blindly reviewed by research staff at UMASS later using the same 5 point imaging scale and categorization. Images will also be reviewed later for identification of specific cardiac landmarks including Mitral Valve, Aortic Valve, Left Ventricle and Right Ventricle.

02

Conditions studied

  • Echocardiography

Keywords

  • Bedside Ultrasound
03

In context

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Physicians with experience in bedside cardiac ultrasound

Exclusion criteria

Exclusion Criteria:

  • Unwilling to consent to study
  • Appropriate ultrasound equipment not available
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherEducation

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

06

What researchers measure

Primary outcomes

  1. Timing of Ultrasound Imaging

    Number of seconds from start to finish of the ultrasound imaging

    Time frame: 10 seconds

Secondary outcomes

  1. Quality of Ultrasound Imaging

    The quality of the ultrasound images based on an ordinal numeric scale of image quality. Minimum =1 and maximum =5. Higher numbers equal better imaging quality. There is no subscale.

    Time frame: 5 seconds

07

Study locations

1 site
  • UMASS Memorial Medical Center
    Worcester, Massachusetts 01655, United States
08

References and documents

Publications

  • 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. PubMed 12119255 ↗
  • 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. PubMed 12969599 ↗
  • 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. PubMed 21763252 ↗
  • 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. PubMed 29175356 ↗
  • 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. PubMed 28754527 ↗
  • 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. PubMed 28349529 ↗

Individual participant data

Plan to share: Yes — Results will be presented at scientific meetings and published in peer reviewed publications.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03927755
Lead sponsor
University of Massachusetts, Worcester
Responsible party
Romolo Gaspari (Professor, Department of Emergency Medicine, University of Massachusetts, Worcester) — Principal investigator
First posted
Apr 25, 2019
Start date
Jun 1, 2019
Primary completion
Dec 31, 2019
Completion
Mar 2, 2020
Last update
Apr 16, 2020

Study contacts

Romolo Gaspari, MD. PhD
principal investigator · UMASS Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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