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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06443567
Other study ID # B01830
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information

Verified date May 2024
Source Manchester University NHS Foundation Trust
Contact ian tyrrell-marsh, MBChB
Phone 01612761234
Email ian.tyrrell-marsh@mft.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
impedance threshold device
impedance threshold device (ResQPOD, Zoll) applied to airway

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Manchester University NHS Foundation Trust North West Ambulance Service nhs foundation trust

Outcome

Type Measure Description Time frame Safety issue
Primary systolic femoral invasive blood pressure 3 mins average with CPR by LUCAS device
Secondary femoral diastolic pressure 3 mins average with CPR by LUCAS device
Secondary femoral arterial pressure, both systolic and diastolic 3 mins average post placement of ICD device
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