Feasibility of Doppler Ultrasound for Pulse Detection in Out-of-Hospital Cardiac Arrest Patients

Cardiac Arrest, Out-Of-Hospital Clinical Trial

Official title:

Doppler Ultrasound Pulse Detection in Out-of-Hospital Cardiac Arrest Patients: A Feasibility Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249893
• Other study ID #: 1549/2023
• Status: Recruiting
• Start date: January 4, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Medical University of Vienna
• Contact: Philipp Metelka, MD
• Phone: +43 699 10659528
• Email: philipp.metelka[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this prospective observational study is to investigate the feasibility of using doppler point-of-care ultrasound on the femoral artery with a portable device to assess the presence of a pulse in patients suffering from cardiac arrest in the out-of-hospital environment. The main question is how often researchers are successful in acquiring the necessary ultrasound signal in the out-of-hospital environment.

Description:

In this prospective observational study, a dedicated research team will be dispatched to cardiac arrest patients treated in the prehospital environment by emergency medical services (EMS). The team will use a portable ultrasound device to identify the femoral artery and conduct a pulsed wave (PW) doppler measurement during chest compressions as well as during chest compression pauses for rhythm analysis and save the recorded images. These ultrasound pulse checks will be conducted in parallel with the normal treatment of the patient, including manual pulse checks, and will only be conducted if ultrasound is possible without interference in the resuscitation. All treatment decisions will rest with the treating EMS team.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Out-of-hospital cardiac arrest treated by EMS

• Minimum age of 18 years

Exclusion Criteria:

• Pregnancy or suspected pregnancy

• Disapproval of the treating EMS team

• Adults under legal guardianship

• Inability to perform femoral artery doppler ultrasound due to limited access to the patient and possible interference with the treating EMS team

• Inability to perform femoral artery doppler ultrasound due to injuries or anatomic abnormalities in the femoral region or necessary emergent medical interventions in the femoral region

• Decision to transfer the patient to the hospital with ongoing CPR for emergent procedures such as extracorporeal CPR before femoral artery doppler ultrasound could be attempted

• Inability to safely perform femoral artery doppler ultrasound due to environmental hazards

Related Conditions & MeSH terms

• Cardiac Arrest, Out-Of-Hospital
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Point-of-care vascular ultrasound
Point-of-care ultrasound will be used to image the femoral vessels and to perform a pulsed-wave doppler measurement of blood flow during chest compressions and during pauses for rhythm and manual pulse checks.

Locations

Country	Name	City	State
Austria	Emergency Medical Service of Vienna	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Emergency Medical Service of Vienna, Ludwig Boltzmann Institute Digital Health and Patient Safety

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of femoral artery doppler ultrasound	If an ultrasound image of the femoral artery of sufficient quality for Doppler ultrasound can be obtained, the primary outcome will be considered to be positive.	During cardiac arrest, up to 45 minutes
Secondary	Time until ultrasound signal acquisition	The time until successful acquisition of the doppler ultrasound signal will be measured in 2-minute CPR-intervals and 30-second intervals (e.g. second CPR-interval, first 30 seconds).	During cardiac arrest, up to 45 minutes
Secondary	Discordance between doppler ultrasound and manual pulse checks.	The presence of a doppler ultrasound flow signal during rhythm analysis and the result of the manual pulse check that is performed in parallel by the treating EMS team will be evaluated and analyzed for discordance.	During cardiac arrest, up to 45 minutes
Secondary	Correlation of the result of manual pulse checks with doppler peak systolic velocity	The correlation of the result of manual pulse checks performed by the treating EMS team with the peak systolic velocity measured by doppler ultrasound will be analyzed.	During cardiac arrest, up to 45 minutes
Secondary	Patient factors influencing probability of successful doppler ultrasound image acquisition	Patient factors sex, age, approximated bodyweight and suspected cause of cardiac arrest will be analyzed for correlation with successful doppler ultrasound image acquisition.	After cardiac arrest, through study completion (a maximum of 1 year)
Secondary	Inter-observer variability in determining the quality of the doppler ultrasound signal.	The sonographer on site will assess the quality of the acquired doppler ultrasound images, as well as two ultrasound experts who will be blinded to the performing sonographer. The difference between these assessments will be analyzed.	After cardiac arrest, through study completion (a maximum of 1 year)