CClinicalTrials.gg
Status unknownNCT05185063RAPID-MIRACLEUpdated Jan 11, 2022

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

An observational study in Out of Hospital Cardiac Arrest, sponsored by King's College London. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by King's College London · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Out of Hospital Cardiac Arrest
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In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Community (i.e. pre-hospital study)

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Out of Hospital Cardiac Arrest

    Diagnostic Test: Point of Care blood test

Interventions

  • Diagnostic testPoint 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.

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What researchers measure

Primary outcomes

  1. Cerebral Performance Category at 30 days

    Cerebral Performance Category

    Time frame: 40 dats

Secondary outcomes

  1. All cause mortality at 30 days

    Death from any cause

    Time frame: 30 days

  2. Cause of Death at 30 days

    Cause of death defined as neurological,multi-organ dysfunction syndrome, cardiac or unrelated

    Time frame: 30 days

  3. Cerebral Performance Category at 6 months

    Cerebral Performance Category

    Time frame: 6 months

  4. All cause mortality at 6 months

    Death from any cause

    Time frame: 6 months

  5. Cause of Death at 6 months

    Cause of death defined as neurological,multi-organ dysfunction syndrome, cardiac or unrelated

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05185063
Lead sponsor
King's College London
Collaborators
London Ambulance Service NHS Trust, King's College Hospital NHS Trust
Responsible party
Sponsor
First posted
Jan 11, 2022
Start date
Mar 1, 2022 (estimated)
Primary completion
Jun 30, 2023 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Jan 11, 2022

Study contacts

Nilesh Pareek, MA,MRCP,PhD
Contact
nileshpareek@nhs.net
02032999000
Nilesh Pareek, MA,MRCP,PhD
principal investigator · King's College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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