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Cardiac ArrestNCT04248985

Effect of Pre-imaging on Cardiopulmonary Resuscitation (CPR) Pause

An observational study of Cardiac Arrest, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients presenting following out of hospital cardiac arrest will undergo bedside ultrasound as per the hospital clinical practice. Initial 6 months include recording of current state of practice and timing of pauses and timing of ultrasounds. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cardiac Arrest
What is being tested?
Pre-Imaging - an ultrasound technique of acquiring images
How many people
150 participants
Where
1 siteUnited States
Study dates
1 Nov 2018to 30 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
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patient presenting to the emergency department in Out of Hospital Cardiac Arrest

Who may be able to join

  • Atruamatic Out of hospital Cardiac Arrest

Who cannot join

  • physician not credentialed in bedside ultrasound
  • video images not recorded (lost data)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Effect of Bedside Ultrasound Pre-imaging on CPR Pauses in Out of Hospital Arrest

Patients presenting following out of hospital cardiac arrest will undergo bedside ultrasound as per the hospital clinical practice. Initial 6 months include recording of current state of practice and timing of pauses and timing of ultrasounds. The second 6 months will follow an educational intervention to teach "pre-imaging". This is the technique of imaging the heart during cardiopulmonary resuscitation (CPR) to find the heart and center it on the ultrasound screen before CPR is stopped. The goal is to decrease CPR pause times when ultrasound is performed post out of hospital (OOH) cardiac arrest.

Read the detailed description

There are two educational Interventions where residents will be trained in how to improve on sonographic imaging techniques performed during resuscitation following cardiac arrest. The two techniques are 1) Sonographic Pre-Imaging and 2) Sonographic Pulse Checks.

Sonographic pre-imaging Sonographic pre-Imaging involves identification of minimal cardiac details when CPR is ongoing. It involves placing the ultrasound transducer on the epigastric region during CPR to identify the general location of the heart and to center the heart in the screen prior to the point when CPR is halted. Pre-imaging produces images of the heart that insufficient for diagnostic evaluation, but allows the clinician to be in place once CPR is halted to obtain higher quality images rapidly.

Residents will be filmed during the resuscitation using two digital video cameras mounted in the resuscitation bay in the Emergency Department. One camera will be isolated to the cardiac monitor display. The other camera will be focused on the area of the room where CPR is performed. The view of this camera will focus on the torso of the patient where CPR and ultrasound imaging occurs. The camera is located in an area of the emergency department where only the patient undergoing resuscitation will be imaged. Filming will be reviewed the following day to record timing measurements of CPR and information on cardiac rhythm during CPR. All video images will be deleted within 3 days of recording to allow for recording over the weekends. No images will be saved.

The study will have three Phases.

Phase 1 - Baseline measurements of CPR activity Residents overseeing resuscitation efforts post-cardiac arrest will be eligible for inclusion in the study when providing care for patients experiencing an out-of-hospital cardiac arrest requiring resuscitation at the University Campus Emergency Department. Education on advanced cardiac life support (ACLS) is standardized through participation in an ACLS training program. A review of ACLS protocols and additional education on the importance of limiting pauses during CPR will be provided to all residents in the residency prior to initialing the study.

Medical records and video recordings will provide information on 1) Patient demographics 2) Resuscitation Interventions 3) Ultrasound Imaging 3) Timing of CPR 4) Cardiac Rhythm. Information on the actions during pauses in CPR will be used to categorize each pause. Pulse Check Pauses are occurrences when CPR is halted to feel for the presence of any pulse. Rhythm Check Pauses are occurrences when CPR is halted to determine the underlying cardiac rhythm. Defibrillation Pauses are occurrences when CPR is halted to deliver defibrillation. Vascular Access Pauses are occurrences when CPR is halted to facility the placement of central or peripheral vascular access. Airway Pauses are occurrences when CPR is halted to facilitate placement of an airway device or check the location of an airway device. Ultrasound Pauses are occurrences when CPR is halted to facilitate ultrasound imaging of the heart. Medication Pauses occur when CPR is halted to deliver intravenous or intra-osseous medications. Rhythm Change Pauses occur when CPR is halted due to a change in rhythm that does not require CPR. Patients may have pauses that involve more than one category, or no pauses at all. Summarized in Table below

Categories of Pauses in CPR Action Occurring During Pause

  1. - Pulse Check Pauses Palpation for pulse in groin or neck
  2. - Rhythm Check Pauses Interpret rhythm on monitor
  3. - Defibrillation Pauses Defibrillate patient
  4. - Vascular Access Pauses Insert peripheral or central vascular access
  5. - Airway Pauses Insert of check location of airway device
  6. - Ultrasound Pauses Obtain ultrasound images of heart
  7. - Medication Pauses Administer medication
  8. - Rhythm Change Pauses Change in rhythm resulting in no need for CPR Primary outcome will be the length and number of pauses in CPR during resuscitation. Measurements will be standardized by length of resuscitation (time patient arrives in emergency department to time resuscitation efforts halted) and multivariate logistic regression will be used to control for variability between patients. Phase 2 - Ultrasound Education Phase - Pre-imaging Education Similar to phase one, Residents overseeing resuscitation efforts post-cardiac arrest will be eligible for inclusion in the study when providing care for patients experiencing an out-of-hospital cardiac arrest requiring resuscitation at the University Campus Emergency Department. Residents will undergo standardized training on sonographic pre-imaging prior to participation in the study. They will be instructed on how to obtain pre-images and how to record images as quickly as possible during pauses in CPR. All measurements and recordings during phase 2 will be identical to phase 1. All other methodologies will remain unchanged. Primary outcome will be the length and number of pauses in CPR during resuscitation. All measurements and recordings during phase 1 and 2 and all other study methodology will be identical to phases 1 and 2. All other methodologies will remain unchanged.
  9. Inclusion/Exclusion Criteria - As appropriate, explain what steps will be taken to insure that subjects meet the criteria (e.g. healthy, not pregnant, etc). Inclusion Residents who have consented to the study will be included during episodes when a patient presents to the Emergency Department in Cardiac Arrest receiving ACLS in the Emergency Department Exclusion
  • Residents who do not consent to the study
  • Residents episodes where resuscitation efforts are terminated due to end of life decisions
  • Residents episodes involving the resuscitation of a trauma patient
  • Residents episodes involving patient who are not imaged with ultrasound during the resuscitation
  1. Discuss the number of experimental and control subjects, and explain the statistical basis for the numbers. There is limited data on pauses during CPR in the emergency department. We assumed that pauses in CPR average 15 seconds based on clinical experience. For the purpose of a power calculation, we assumed that education on pre-imaging will decrease pauses during ultrasound imaging by 5 seconds and imaging in the groin will decrease pauses by 10 seconds. Assuming an 80% power and an alpha of 0.05 we need 79 patients in phase one and 63 patients in phase two and 16 patients in phase three. Because of clustering around individual providers we will need to enroll two times that amount be account for clustering by provider. This means we need to enroll a total of 300 patients. Phase 3 - Sonographic Pulse Checks - Exploring the use of doppler imaging of the femoral artery during and between CPR to replace palpation of the pulse. Similar to phases one and two, residents overseeing resuscitation efforts post-cardiac arrest will be eligible to participate in the study when providing care for patients experiencing an out-of-hospital cardiac arrest requiring resuscitation at the Emergency Department. Clinicians or research staff will perform sonographic pulse checks by imaging the femoral or cardiac artery and visualize any flow within the vessel. Sonographic pulse checks will occur either a) during CPR b) during pauses in CPR c) during transitions from CPR to pause or d) during transition from pause to CPR. Patient inclusion and exclusion criteria are identical to phase 1 and 2. Patients will undergo standard of care as per UMass practice. This includes ACLS interventions based on published ACLS protocols. During pauses in CPR clinicians perform brief echocardiography of the heart, with attention to not delaying CPR pauses. During the same pause doppler imaging of the CFV will be performed by research or clinical staff. Clips of any of the 4 time periods listed above will be digitally recorded. Simultaneous clips of the patients heart will be digitally recorded. Patients will be followed to survival endpoints including a) ROSC b) survival to hospital admission c) survival to hospital discharge and d) death in ED. Survival endpoints will be abstracted from the medical record. Digital images will be de-identified and paired by patient and pause. (Patient X, pause 1; Patient X, pause 2...). Interpretation of the brief echo will be to identify the presence or absence of cardiac activity and to identify if the cardiac activity is organized or not. In addition, the images will be reviewed to identify ventricular fibrillation. Interpretation of the CVF doppler images will be performed to identify a) VTI and maximal velocity of arterial pulses from CPR b) VTI and maximal velocities of arterial pulses secondary to cardiac activity c) Rate and regularity of CPR pulses, d) rate and regularity of cardiac activity pulses e) inherent noise level of doppler signal between pulses. This is a proof-of-concept, descriptive study without a specific power analysis. The goal is to describe the amount of cardiac activity as visualize during brief echo that corresponds to measurable pulse activity by doppler. The secondary goal is to determine if the presence of an "irregular pulse" during regular CPR is associated with ROSC.
Conditions
Cardiac Arrest
Being tested
Pre-Imaging - an ultrasound technique of acquiring images
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-Imaging - an ultrasound technique of acquiring imagesOther

    Technique involves finding low quality images of the heart during CPR prior to pausing CPR to acquire high quality images once CPR is paused.

Study groups in NCT04248985
Study groupRoleWhat they receive
Pre-InterventionBaseline measurement of timing and behavior in OOH cardiac arrest patients presenting with ongoing CPR.
Receives: Other: Pre-Imaging - an ultrasound technique of acquiring images
Post-InterventionTiming and behavior in OOH cardiac arrest patents presenting with ongoing CPR
Receives: Other: Pre-Imaging - an ultrasound technique of acquiring images

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of CPR pause

    the time between stopping CPR and restoring CPR during resuscitation.

    Measured: 1 year

Secondary outcomes (1)
  1. Survival

    survival to hospital discharge

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start1 Nov 2018
  3. Primary completion30 Nov 2019
  4. Study completion30 Mar 2020

Resources

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
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248985
Sponsor's protocol ID
UMASS-CPR2019
Status last verified
Jul 2020
First submitted
24 Jan 2020
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gaspari RJ, Lindsay R, Dowd A, Gleeson T. Femoral Arterial Doppler Use During Active Cardiopulmonary Resuscitation. Ann Emerg Med. 2023 May;81(5):523-531. doi: 10.1016/j.annemergmed.2022.12.002. Epub 2023 Feb 7.

    PubMed 36754697

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrest, 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 8 Feb 2022. 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?

Length of CPR pause (time frame: 1 year). 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 NCT04248985, which also lists 1 linked publication.

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 8 Feb 2022.

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