NCT06922019

Brief Summary

This research will explore ambulance clinicians' experiences of attending out of hospital cardiac arrest (OHCA) incidents involving children. OHCA occurs when the heart stops beating. This is a time critical emergency that requires immediate treatment to maximise the changes of survival. OHCA affecting children is rare, but when it happens it is vital that paramedics and other ambulance clinicians can respond and deliver high quality care. Because OHCA in children is rare, ambulance clinicians attend these incidents infrequently. Some clinicians may only ever attend this type of incident once in their career. These incidents are technically challenging for ambulance clinicians, and highly stressful. Evidence from other setting suggests that clinicians may be ill-prepared to manage these events. This research aims to understand how OHCA incidents involving children are currently managed, and to explore the views and experiences of ambulance clinicians with respect to attending OHCA incidents involving children. By learning from what is currently being done, and from clinicians' experiences, the research team aims to develop recommendations for how the response to these patients, and the support provided to ambulance clinicians, could be improved. The research team will review the records of patients under the age of 18 who have been treated for OHCA by one ambulance service over a four-year period. Data will be collected from these records to allow the care delivered to be compared to international guidelines, and to explore what factors might influence the delivery of this care. The research will also involve a survey of ambulance clinicians working across the UK to understand their experiences, and how prepared they feel to attend these incidents. Finally, the research team will undertake interviews with clinicians who have been involved in the management of a child with OHCA and focus group discussions with specialist clinicians to allow us to learn from their experiences.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,137

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
May 2025Jan 2027

First Submitted

Initial submission to the registry

February 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

February 12, 2025

Last Update Submit

April 8, 2025

Conditions

Keywords

out of hospital cardiac arrestpaediatricchildrenambulanceemergency medical service

Outcome Measures

Primary Outcomes (3)

  • Delivery of treatment in compliance with European Resuscitation Council Guidelines (work package one)

    Proportion of cases that receive treatment that complies with European Paediatric Advanced Life Support guidelines.

    During cardiac arrest event (until handover at hospital or termination of resuscitation)

  • Preparedness of clinicians to attend OHCA involving children (work package two)

    Measured using self-reported Likert scale

    Baseline (defined as the date of survey completion)

  • Clinician experiences of attending OHCA incidents involving children (work package three)

    Measured through inductive thematic analysis of interviews and focus groups - data from interviews and focus groups will be combined and analysed thematically as one dataset to describe the overall experience of ambulance clinicians.

    Baseline (defined as the date of interview/focus group participation)

Secondary Outcomes (1)

  • Proportion of participants with moderate or high levels of symptoms consistent with PTSD following attending an OHCA incident involving a child (work package two)

    Baseline (defined as the date of survey completion)

Study Arms (5)

Out of hospital cardiac arrest patients

Data will be collected relating to approximately 600 patients aged \<18 years who were treated for out of hospital cardiac arrest by one UK ambulance service between 2021 and 2024

Survey participants

Approximately 1,500 ambulance clinicians employed by National Health Service (NHS) ambulance trusts across the UK who participate in an online survey.

Interview participants (recent exposure)

Approximately 12-15 ambulance clinicians with recent (\<12 months) exposure to an out of hospital cardiac arrest incident involving a child, who will participate in a semi-structured interview.

Interview participants (historic exposure)

Approximately 3-4 ambulance clinicians with historic (\>12 months) exposure to an out of hospital cardiac arrest incident involving a child, who will participate in a semi-structured interview.

Focus group participants

Up to 18 advanced/critical care paramedics who will participate in focus group discussions.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The out of hospital cardiac arrest patient group will include patients aged \<18 years who were treated for out of hospital cardiac arrest by the London Ambulance Service NHS Trust. The survey, interview and focus group participants will be made up of ambulance clinicians employed in an NHS ambulance trust in the UK. * Survey participants in the recent exposure group will have recently attended an out of hospital cardiac arrest involving a child * Survey participants in the historic exposure group will have attended an out of hospital cardiac arrest involving a child \>12 months before the interview date * Focus group participants will be specialist critical care paramedics who attend out of hospital cardiac arrest incidents involving children

You may qualify if:

  • Patients attended by London Ambulance Service NHS Trust (LAS)
  • Incidents occurring between January 2021 and December 2024
  • Out of Hospital Cardiac Arrest recognised by LAS clinicians
  • Aged under 18 years at the time the incident occurred

You may not qualify if:

  • New born patients who had not taken their first spontaneous breath before cardiac arrest was recognised
  • Incidents occurring outside of LAS' operational area (Greater London, UK)
  • Patients who have registered an NHS National Data Opt-Out
  • Survey participants
  • Ambulance clinician (including registered healthcare professionals and non-registered ambulance clinicians)
  • Currently responds to 999 calls (face to face) as part of their role
  • Would be expected to attend a paediatric OHCA incident as part of their role
  • Consents to participate in study
  • Non-clinical ambulance service employee
  • Not employed by an NHS Ambulance Service in the UK
  • Interview participants (recent exposure)
  • Ambulance clinician (including registered healthcare professionals and non-registered ambulance clinicians)
  • Employed by a participating NHS Ambulance Service Site
  • Attended an out of hospital cardiac arrest incident involving a child (\>1 day old, \< 18 years old) in the 12 months prior to the proposed interview date
  • Consents to participation in the study
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Warwick

Coventry, CV4 7AL, United Kingdom

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Central Study Contacts

Adam Mellett-Smith, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2025

First Posted

April 10, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations