Cardiac ArrestNCT03476720
Improving Defibrillation Pad Position
An observational study of Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Pad positioning according to a manufacturer's diagram
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 4 Sep 2018
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All adults who have had no training in basic life support or public access/AED defibrillation.
Who may be able to join
- 16 yrs age and willing to participate.
Who cannot join
- Previous BLS training
- Previous AED training
- Clinical staff (doctor, nurse, HCA, paramedic etc)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO16 6YD
About this study
Official title: Accuracy of Instructional Diagrams for Automated External Defibrillator (AED) Pad Positioning
Manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy.
We will ask untrained members of the public to observe the diagrams and place pads as indicated on the diagram. We will asses the accuracy of pad placement and repeat the study using an anatomically correct diagram to see if we can improve the accuracy of pad placement.
Read the detailed description
As above
- Conditions
- Cardiac Arrest
- Being tested
- Pad positioning according to a manufacturer's diagram
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pad positioning according to a manufacturer's diagramDevice
Placement of defibrillation pads according to the diagram
What is being measured
The primary outcome is the main question the study is designed to answer.
Pad position
Position of the pad (vertical and horizontal) in relation to optimal position as recommended by the resuscitation guidelines.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 May 2018
- Primary completion1 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Deakin, MD, Study director, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476720
- Sponsor's protocol ID
- TBC
- Status last verified
- Oct 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Instructional Diagrams for Automated External Defibrillator (AED) Pad Positioning
- ClinicalTrials.gov ID
- NCT03476720
- Acronym / sponsor ID
- TBC
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 26 Mar 2018 (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.
Manufacturer's diagrams showing defibrillation pad positioning (as used on public access defibrillators) are anatomically incorrect and are likely to lead to poor position of defibrillation pads, with reduced defibrillation efficacy.
We will ask untrained members of the public to observe the diagrams and place pads as indicated on the diagram. We will asses the accuracy of pad placement and repeat the study using an anatomically correct diagram to see if we can improve the accuracy of pad placement.
Detailed description
As above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adults who have had no training in basic life support or public access/AED defibrillation.
Key inclusion criteria (1 listed)
- 16 yrs age and willing to participate.
Key exclusion criteria (3 listed)
- Previous BLS training
- Previous AED training
- Clinical staff (doctor, nurse, HCA, paramedic etc)
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 |
|---|---|---|
| Pad positioning according to a manufacturer's diagramPlacement of defibrillation pads according to the diagram | Device | – |
Primary outcome
Pad position
Time frame: 6 months
Position of the pad (vertical and horizontal) in relation to optimal position as recommended by the resuscitation guidelines.
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 22 Oct 2018.
- 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.
Charles Deakin, MD study director
University Hospital Southampton NHS Foundation Trust
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 Cardiac Arrest, run by University Hospital Southampton NHS Foundation Trust 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 1 inclusion and 3 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 22 Oct 2018. 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?
Pad position (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2018.