Developing a Digital Handover Application for Paramedics... | NCT05185063

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Estimated

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Mar 1, 2024Estimated

First Submitted Date

Dec 23, 2021

First Submission Date that Met QC Criteria

Dec 23, 2021

First Posted Date

Jan 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2021

Last Update Posted Date

Jan 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

King's College LondonOTHER

Collaborators

Name	Class
London Ambulance Service NHS Trust	OTHER
King's College Hospital NHS Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Out of Hospital Cardiac Arrest			Diagnostic Test: Point of Care blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Point of Care blood test	Diagnostic 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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community (i.e. pre-hospital study)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nilesh Pareek, MA,MRCP,PhD	Contact	02032999000		nileshpareek@nhs.net

Overall Officials

Name	Affiliation	Role
Nilesh Pareek, MA,MRCP,PhD	King's College London	Principal Investigator

Locations

Not provided

References Module

Citations

Not provided

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases