ResuscitationNCT04478786
Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device.
An observational study of Resuscitation, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Should a person have a cardiac arrest (where their heart stops beating) they require treatment of cardiopulmonary resuscitation (CPR). This includes providing chest compressions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resuscitation
- What is being tested?
- Focus group discussion
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2020to 19 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Operational ambulance crew employees of the local ambulance service
Who may be able to join
- aged 18 or over
- an employee of the local ambulance service
- employed as an operational ambulance crew member, irrespective of title
- to have experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement.
Who cannot join
- not an employee of the local ambulance service
- have no experience of using a mechanical chest compression device at an out of hospital resuscitation
- the participant is unwilling to provide consent to participate
- the participant is unwilling to provide consent to be audio recorded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North East Ambulance Service NHS Foundation Trust
Newcastle upon Tyne, NE15 8NY
About this study
Official title: What Are Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device for Out-of-hospital Resuscitation? A Constructivist Qualitative Study Utilising Online Focus Groups
Should a person have a cardiac arrest (where their heart stops beating) they require treatment of cardiopulmonary resuscitation (CPR). This includes providing chest compressions. Traditionally these compressions are provided by hand but mechanical chest compression devices (MCCD) have been investigated for use in out of hospital resuscitation attempts.
Research trials recruiting human participants have concluded recently. They all found no difference in survival outcomes when MCCD and manual compressions were compared.
Despite this, the latest expert review on MCCD suggests that MCCD can be a reasonable alternative to high quality manual compressions when these cannot be provided. MCCD continue to be used by Specialists in the local ambulance service and historically by those recruiting patients to a national multi centre trial of MCCD. There is another, as yet under-investigated element, and that is of ambulance crews' experiences of using such devices. Therefore it is a reasonable topic to investigate.
Read the detailed description
This study will invite local United Kingdom (UK) National Health Service (NHS) operational ambulance crews to participate in a 1-2 hour online focus group discussion (a collective group discussion) about their experiences of using MCCD. The participants will be any operational ambulance crew member, employed by the local ambulance Trust and who had experience of using any type of MCCD. The focus groups will be audio recorded; participants will be aware of this when they choose to participate.
The aim of this research is to collect and report ambulance crews' experiences of using mechanical chest compression devices for out of hospital resuscitation attempts.
Ultimately there may of course be benefits for patients by exploring whether MCCD play a part in out of hospital resuscitations. Funding has been offered by a manufacturer one of the types of MCCD; they have had no involvement in the design or analysis of the study.
Once transcribed, the data will be analysed manually. The content of each focus group will be coded and then each participants' individual responses will be coded, first using open coding, then focused coding to identify emergent themes, before concluding with the categories that have been identified. The constant comparison method of data analysis will be used.
- Conditions
- Resuscitation
- Being tested
- Focus group discussion
- Keywords
- Cardiopulmonary Resuscitation,, Resuscitation, Out of Hospital, Ambulance Crew, Mechanical Chest Compression Device, Qualitative, Experiences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group discussionOther
There is no intervention. This is a qualitative piece of work only.
| Study group | Role | What they receive |
|---|---|---|
| Focus Groups 1-4 | An anticipated 3-8 participants who meet the inclusion criteria of being aged 18 or over, a employee of the local ambulance service, are employed as an operational ambulance crew member, irrespective of title and to have had experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement, and who also volunteer and agree to take part in the online focus group. Receives: Other: Focus group discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect and report ambulance crews' experiences of using MCCDs for out-of-hospital resuscitation attempts.
The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start31 Jul 2020
- Primary completion19 Sep 2020
- Study completion19 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Jolife AB
- Responsible party
- Sponsor
- Investigators
- Richelle Duffy, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478786
- Sponsor's protocol ID
- 18018/275607
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blair L, Duffy R. What are ambulance crews' experiences of using a mechanical chest compression device for out-of-hospital resuscitation? A constructivist qualitative study utilising online focus groups. Br Paramed J. 2022 Sep 1;7(2):24-30. doi: 10.29045/14784726.2022.09.7.2.24.
PubMed 36451709
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device for Out-of-hospital Resuscitation? A Constructivist Qualitative Study Utilising Online Focus Groups
- ClinicalTrials.gov ID
- NCT04478786
- Acronym / sponsor ID
- 18018/275607
- Conditions
- Resuscitation
- Keywords
- Cardiopulmonary Resuscitation,, Resuscitation, Out of Hospital, Ambulance Crew, Mechanical Chest Compression Device, Qualitative, Experiences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Jolife AB
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 19 Sep 2020 (actual)
- Study completion
- 19 Sep 2020 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Should a person have a cardiac arrest (where their heart stops beating) they require treatment of cardiopulmonary resuscitation (CPR). This includes providing chest compressions. Traditionally these compressions are provided by hand but mechanical chest compression devices (MCCD) have been investigated for use in out of hospital resuscitation attempts.
Research trials recruiting human participants have concluded recently. They all found no difference in survival outcomes when MCCD and manual compressions were compared.
Despite this, the latest expert review on MCCD suggests that MCCD can be a reasonable alternative to high quality manual compressions when these cannot be provided. MCCD continue to be used by Specialists in the local ambulance service and historically by those recruiting patients to a national multi centre trial of MCCD. There is another, as yet under-investigated element, and that is of ambulance crews' experiences of using such devices. Therefore it is a reasonable topic to investigate.
Detailed description
This study will invite local United Kingdom (UK) National Health Service (NHS) operational ambulance crews to participate in a 1-2 hour online focus group discussion (a collective group discussion) about their experiences of using MCCD. The participants will be any operational ambulance crew member, employed by the local ambulance Trust and who had experience of using any type of MCCD. The focus groups will be audio recorded; participants will be aware of this when they choose to participate.
The aim of this research is to collect and report ambulance crews' experiences of using mechanical chest compression devices for out of hospital resuscitation attempts.
Ultimately there may of course be benefits for patients by exploring whether MCCD play a part in out of hospital resuscitations. Funding has been offered by a manufacturer one of the types of MCCD; they have had no involvement in the design or analysis of the study.
Once transcribed, the data will be analysed manually. The content of each focus group will be coded and then each participants' individual responses will be coded, first using open coding, then focused coding to identify emergent themes, before concluding with the categories that have been identified. The constant comparison method of data analysis will be used.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Groups 1-4 | – | Other: Focus group discussionAn anticipated 3-8 participants who meet the inclusion criteria of being aged 18 or over, a employee of the local ambulance service, are employed as an operational ambulance crew member, irrespective of title and to have had experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement, and who also volunteer and agree to take part in the online focus group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Operational ambulance crew employees of the local ambulance service
Key inclusion criteria (4 listed)
- aged 18 or over
- an employee of the local ambulance service
- employed as an operational ambulance crew member, irrespective of title
- to have experienced an out of hospital resuscitation where MCCD was used, irrespective of the type of device or their level of involvement.
Key exclusion criteria (4 listed)
- not an employee of the local ambulance service
- have no experience of using a mechanical chest compression device at an out of hospital resuscitation
- the participant is unwilling to provide consent to participate
- the participant is unwilling to provide consent to be audio recorded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group discussionThere is no intervention. This is a qualitative piece of work only. | Other | Focus Groups 1-4 |
Primary outcome
Collect and report ambulance crews' experiences of using MCCDs for out-of-hospital resuscitation attempts.
Time frame: 2 hours
The transcribed discussions will be coded and then themes emerging from the data identified and developed. To do this I will use a constant comparison method of analysis. The presence or lack of consensus and reinforcement on certain topics will also be observed for.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Results publication: PubMed 36451709Blair L, Duffy R. What are ambulance crews' experiences of using a mechanical chest compression device for out-of-hospital resuscitation? A constructivist qualitative study utilising online focus groups. Br Paramed J. 2022 Sep 1;7(2):24-30. doi: 10.29045/14784726.2022.09.7.2.24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richelle Duffy, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resuscitation, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect and report ambulance crews' experiences of using MCCDs for out-of-hospital resuscitation attempts. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.