- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06443567
Arterial Blood Pressure and Cardiac Arrest (ABaCAS)
To describe and measure diastolic and systolic femoral arterial pressure during medical cardiac arrest.
To define baseline measures. To describe and measure arterial blood pressure after placement of an ITD device.
To observe the diastolic pressure immediately prior to return of spontaneous circulation.
To quantify and describe the effects of intravenous adrenaline on arterial blood pressure in cardiac arrest.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cardiac arrest is a complex disorder whose outcome is reliant on a huge number of factors. Moreover, many interventions are time critical, therefore an intervention that may be lifesaving if given early, may have no benefit if instigated further in the disease course. For these reasons' studies involving cardiac arrest are incredibly difficult to carry out and interpret. Many of the interventions carried out during cardiac arrest are aimed at improving blood pressure and thereby increasing the amount of blood and oxygen delivered to the myocardium in the hopes of achieving a return of spontaneous circulation (ROSC). However current data on what a 'normal' blood pressure, based largely upon non-invasive measurement, during cardiac arrest is severely limited, making comparison and evaluation of interventions extremely difficult. This provides the basis for this study in order to prospectively collate and describe data from invasive blood pressure monitoring during adult, medical cardiac arrest in the pre-hospital environment.
3. Research Question/Aim(s) To measure and describe femoral arterial pressure during cardiac arrest with mechanical CPR by a LUCAS device. 3.1 Objectives Primary objective To quantify and describe baseline arterial systolic blood pressure as measured by an invasive femoral line in adult patients suffering medical cardiac arrest in the pre-hospital setting. This will be defined as a line of best fit for systolic blood pressure superimposed on the arterial trace during a 3 minute period.
Secondary Objectives
- To quantify and describe baseline arterial diastolic blood pressure as measured by an invasive femoral line in adult patients suffering medical cardiac arrest in the pre-hospital setting. This will be defined as a line of best fit for diastolic blood pressure superimposed on the arterial trace during a 3 minute period.
- To quantify and describe arterial blood pressure after the placement of an ITD device over a 3 minute period.
- To quantify and describe the effect of intravenous adrenaline on blood pressure as administered in line with ALS guidelines (every 3-5 mins) in adult patients in cardiac arrest.
- To document the diastolic blood pressure of those patients that achieve return of spontaneous circulation (ROSC) following out of hospital cardiac arrest.
Study Type
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Adult patients (18+) suffering an out of hospital cardiac arrest (OHCA) by a presumed medical cause that have been deemed suitable to attempt resuscitation of.
All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage, and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise.
Description
Inclusion Criteria:
- Adult patients (≥18years) in medical cardiac arrest
- Deemed suitable to attempt resuscitation.
Exclusion Criteria:
- Prisoners
- <18years
- Pregnancy
- Traumatic cardiac arrest
- Arrest caused by hypovolaemia, tension or tamponade as determined by the clinical team on scene
- Inability to secure a patent airway.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
adult cardiac arrest
blood pressure measurement pre and post impedance threshold device placement
|
impedance threshold device (ResQPOD, Zoll) applied to airway
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
systolic femoral invasive blood pressure
Time Frame: 3 mins average with CPR by LUCAS device
|
3 mins average with CPR by LUCAS device
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
femoral diastolic pressure
Time Frame: 3 mins average with CPR by LUCAS device
|
3 mins average with CPR by LUCAS device
|
|
femoral arterial pressure, both systolic and diastolic
Time Frame: 3 mins average post placement of ICD device
|
3 mins average post placement of ICD device
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B01830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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