Do Patients Suffering a Cardiac Arrest Present to the Amb... | NCT04604639

Studies
Do Patients Suffering a Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?

NCT04604639

Sponsor

University Hospital Southampton NHS Foundation Trust

Status

Completed

Last Update Posted

Apr 13, 2022Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Cardiac Arrest

Interventions

NEWS2 score

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Feb 19, 2020Actual

Completion Date

Feb 20, 2020Actual

First Submitted Date

Oct 21, 2020

First Submission Date that Met QC Criteria

Oct 21, 2020

First Posted Date

Oct 27, 2020Actual

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

Apr 5, 2022

Last Update Posted Date

Apr 13, 2022Actual

Name	Class
South Central Ambulance Service NHS Foundation Trust	UNKNOWN

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.

Detailed Description

The UK ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (OHCA) each year. Hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (IHCA) have been deteriorating for the preceeding 48 hrs and suggest that many IHCA are potentially avoidable if this deterioration is identified and actued on promptly. No similar study has been performed to see if patients suffering OHCA have also presented with warning signs in the preceeding 48 hrs that were overlooked.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Out-of-hospital cardiac arrest		Patients suffering an out-of-hospital cardiac arrest to who the ambulance service was requested to attend.	Diagnostic Test: NEWS2 score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NEWS2 score	Diagnostic Test	Patients seen by ambulance crews within the preceeding 48 hrs of their cardiac arrest will have a NEWS2 score performed to assess the level of physiological deterioration at the time of thei intial assessment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Out-of-hospital cardiac arrest	Cardiac arrest following ambulance assessment	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• All patients seen by SCAS ambulance crews and suffering a cardiac arrest within the following 48 hrs

Exclusion Criteria:

• None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients calling for an emergency ambulance in the South Central Ambulance Service region, where an emergency ambulnace was dispatched and a patient intervention occurred.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles D Deakin, MD	Divisional Medical Director	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Central Ambulance Service		Otterbourne	Hampshire	SO21 2RU	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided