Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04248985 |
| Other study ID # |
UMASS-CPR2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
March 30, 2020 |
Study information
| Verified date |
July 2020 |
| Source |
University of Massachusetts, Worcester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
b. 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
c. 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.
