Ambulance Crews' Experiences of Using a Mechanical Chest Compression Device.

October 11, 2022 updated by: Northumbria University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE15 8NY
        • North East Ambulance Service NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Operational ambulance crew employees of the local ambulance service

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Focus group discussion
There is no intervention. This is a qualitative piece of work only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Does the use of MCCDs have any effect on, or facilitate, the team leader role at an out-of-hospital resuscitation attempt
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.
2 hours
Does providing mechanical versus manual chest compressions have an effect on how ambulance crews feel physically and emotionally after an out-of-hospital resuscitation attempt.
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.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northumbria University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jolife AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richelle Duffy, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18018/275607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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