EchocardiographyREASON-2NCT03927755
Timing For Single View Bedside Cardiac Ultrasound
An observational study of Echocardiography, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Echocardiography
- What is being tested?
- Education
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All physicians participating in existing ultrasound educational programs will be considered for enrollment.
Who may be able to join
- Physicians with experience in bedside cardiac ultrasound
Who cannot join
- Unwilling to consent to study
- Appropriate ultrasound equipment not available
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: REASON 2 Trial - Timing For Single View Bedside Cardiac Ultrasound
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.
- Conditions
- Echocardiography
- Being tested
- Education
- Keywords
- Bedside Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Physicians will undergo training on how to rapidly obtain appropriate images.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of Ultrasound Imaging
Number of seconds from start to finish of the ultrasound imaging
Measured: 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.
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2019
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romolo Gaspari, University of Massachusetts, Worcester
- Investigators
- Romolo Gaspari, MD. PhD, Principal investigator, UMASS Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927755
- Sponsor's protocol ID
- UMASS-ED-4-22-19
- Acronym
- REASON-2
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2019
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be presented at scientific meetings and published in peer reviewed publications.
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 12119255Steen 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 12969599Vaillancourt 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 21763252Clattenburg 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 29175356Huis 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 28754527Zhan 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REASON 2 Trial - Timing For Single View Bedside Cardiac Ultrasound
- ClinicalTrials.gov ID
- NCT03927755
- Acronym / sponsor ID
- REASON-2 / UMASS-ED-4-22-19
- Conditions
- Echocardiography
- Keywords
- Bedside Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-xyphoid | – | Other: EducationUltrasound 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. |
| Para-sternal Long | – | Other: EducationUltrasound 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All physicians participating in existing ultrasound educational programs will be considered for enrollment.
Key inclusion criteria (1 listed)
- Physicians with experience in bedside cardiac ultrasound
Key exclusion criteria (2 listed)
- Unwilling to consent to study
- Appropriate ultrasound equipment not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationPhysicians will undergo training on how to rapidly obtain appropriate images. | Other | Para-sternal Long, Sub-xyphoid |
Primary outcome
Timing of Ultrasound Imaging
Time frame: 10 seconds
Number of seconds from start to finish of the ultrasound imaging
1 secondary outcome
Quality of Ultrasound Imaging
Time frame: 5 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Background: PubMed 12119255Yu 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.
- Background: PubMed 12969599Steen 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.
- Background: PubMed 21763252Vaillancourt 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.
- Background: PubMed 29175356Clattenburg 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.
- Background: PubMed 28754527Huis 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.
- Background: PubMed 28349529Zhan 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.
- Individual participant dataSharing planned: Yes. Results will be presented at scientific meetings and published in peer reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romolo Gaspari, MD. PhD principal investigator
UMASS Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of Ultrasound Imaging (time frame: 10 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927755, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.