Developing a Digital Handover Application for Paramedics to Provide a Personalized Approach to Pre-hospital Stratification for Out of Hospital Cardiac Arrest (RAPID-MIRACLE)

A prospective study validating the role of the MIRACLE2 score in patients with resuscitated out of hospital cardiac arrest in a pre-hospital setting.

Study Overview

• Status: Not yet recruiting
• Conditions: Out of Hospital Cardiac Arrest
• Intervention / Treatment: Diagnostic test: Point of Care blood test

Detailed Description

Design: Prospective observational cohort study enrolling OOHCA patients across London in a pre-hospital setting

Study Protocol: Patients with OOHCA and ROSC will be recruited from the community into the study by London Ambulance Service NHS Trust (LAS). LAS has -40 Advanced Paramedic Practitioners in Critical Care (APP-CC) who have a range of specialist skills including airway management and focused ultrasound and attend to over 1500 OOHCAs/year.

Point of Care pH test: The recruited participants will have point of care pH testing performed using the CG4+ iStat system (Abbott Vascular, Illinois, U.S.A.). The test requires 2ml of venous blood and can provide blood results within minutes. The device and blood taking system have received CE marking and are already in routine use across the NHS. Once the blood results are received, the blood sample and testing system are discarded in a routine manner.

Standard Care: Participants will then be conveyed to either the local emergency department or to a HAC based on current routine protocols. Patients will be treated in a routine manner after reaching secondary care in accordance with local and national guidance with no change in care based on this study.

Power calculation: In 2019, APP-CCs from LAS attended to -700 OOHCA patients with ROSC. Assuming 60% recruitment, we could comfortably envisage -500 patients to be recruited in a 15 month period. From previous data, we can expect approximately 60% of the patients (n=300) to have a CPC score of 3-5 on hospital discharge. This would be of a similar size to the dataset used to derive the original score, which gave good levels of accuracy in model performance measures.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Nilesh Pareek, MA,MRCP,PhD; Phone Number: 02032999000; Email: nileshpareek@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Community (i.e. pre-hospital study)

Description

Inclusion Criteria:

• Patients with out of hospital cardiac arrest with sustained ROSC (defined as >20 minutes or sufficient stability to consider conveyance)

Exclusion Criteria:

• Any clear non-cardiac cause of arrest (trauma, drowning Overdose, asphyxia, asthma, anaphylaxis).
• Suspected or confirmed intra-cerebral bleeding
• Known CPC score 3 or 4 pre-cardiac arrest
• Known disease limiting survival to 6 months
• Suspected or known pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Out of Hospital Cardiac Arrest	Diagnostic test: Point of Care blood test; The pH will be incorporated into the MIRACLE2 score in a pre-hospital setting. The patients will continue to be treated with standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral Performance Category at 30 days	Cerebral Performance Category	40 dats

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality at 30 days	Death from any cause	30 days
Cause of Death at 30 days	Cause of death defined as neurological,multi-organ dysfunction syndrome, cardiac or unrelated	30 days
Cerebral Performance Category at 6 months	Cerebral Performance Category	6 months
All cause mortality at 6 months	Death from any cause	6 months
Cause of Death at 6 months	Cause of death defined as neurological,multi-organ dysfunction syndrome, cardiac or unrelated	6 months

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: King's College Hospital NHS Trust; London Ambulance Service NHS Trust
• Investigators: Principal Investigator: Nilesh Pareek, MA,MRCP,PhD, King's College London

Publications and helpful links

Helpful Links

• Heart Research United Kingdom - Novel Emerging Technology Grant

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 301864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No