Cardiac ArrestNCT02073539
The Manikin Study of Chest Compression With One Accelerometer Feedback Device
A study testing Stryker ST104-747 and Shinchang SB-34p in people with Cardiac Arrest, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
Chest compression (CC) feedback devices are used to perform CC measurements effectively and accurately on patients in hospital beds. However, these devices do not take account of the compression of the mattress, which results in overestimation of CC depth. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Stryker ST104-747 and Shinchang SB-34p
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Mar 2014
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postgraduates year 1,2,3,4 and Emergency physicians in emergency department
Who cannot join
- Wrist or Low back disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Method of Proper Chest Compression Depth With Conventional and One Accelerometer Feedback Device During CPR in Hospital
Chest compression (CC) feedback devices are used to perform CC measurements effectively and accurately on patients in hospital beds. However, these devices do not take account of the compression of the mattress, which results in overestimation of CC depth. This study is the validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to overcome this limitation and thus measure compression depth more accurately when performing cardiopulmonary resuscitation (CPR) on patients.
Read the detailed description
Data collection The participants will be divided into three groups by random drawings. Each performer in the three-groups will compress the chest of the manikin on the bed with real-time 5cm,6cm and 7cm feed-back by one accelerometer (U-cpr).We will use two beds [Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US) ,Shinchang SB-34p (Transport stretcher® , 850 x 2080 mm,Shinchang Co.,Busan,ROK)]. Each participants will do 6 cycles of chest compression and 1cyle will be 2minutes. Between each cycles, participants will take a rest 5minutes.
- Conditions
- Cardiac Arrest
- Being tested
- Stryker ST104-747, Shinchang SB-34p
- Keywords
- Chest compression, One accelerometer, Manikin Study
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker ST104-747Device
Also called Transport stretcher®
760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US
Shinchang SB-34pDevice
Also called Transport stretcher®
, 850 x 2080 mm,Shinchang Co.,Busan,ROK
| Study group | Role | What they receive |
|---|---|---|
| chest compression with 5cm feedback | Experimental | We will feedback by one accelerometer (U-cpr). U-cpr is android based smartphone application. Receives: Device: Stryker ST104-747; Device: Shinchang SB-34p |
| chest compression with 6cm feedback | Experimental | We will feedback by one accelerometer(U-cpr). U-cpr is android based smartphone application. Receives: Device: Stryker ST104-747; Device: Shinchang SB-34p |
| chest compression with 7cm feedback | Experimental | We will feedback by one accelerometer(U-cpr). U-cpr is android based smartphone application. Receives: Device: Stryker ST104-747; Device: Shinchang SB-34p |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compression depth
Primary out come is measured by Resusci Anne Modular System Skill Reporter manikin (9.89 kg, Laerdal Medical, Orpington, UK)
Measured: Within 1day
Secondary outcomes (1)
Chest compression rate
Secondary out is measured by Resusci Anne Modular System Skill Reporter manikin (9.89 kg, Laerdal Medical, Orpington, UK).
Measured: Within 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Sang Hyun, Hanyang University Seoul Hospital
- Investigators
- Sang hyun Lee, M.D, Principal investigator, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073539
- Sponsor's protocol ID
- 2013-12-010-001
- Status last verified
- Mar 2014
- First submitted
- 24 Feb 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Method of Proper Chest Compression Depth With Conventional and One Accelerometer Feedback Device During CPR in Hospital
- ClinicalTrials.gov ID
- NCT02073539
- Acronym / sponsor ID
- 2013-12-010-001
- Conditions
- Cardiac Arrest
- Keywords
- Chest compression, One accelerometer, Manikin Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Feb 2014 (estimated)
- 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.
Chest compression (CC) feedback devices are used to perform CC measurements effectively and accurately on patients in hospital beds. However, these devices do not take account of the compression of the mattress, which results in overestimation of CC depth. This study is the validation study to demonstrate that a new method using one accelerometer(U-cpr) is useful to overcome this limitation and thus measure compression depth more accurately when performing cardiopulmonary resuscitation (CPR) on patients.
Detailed description
Data collection The participants will be divided into three groups by random drawings. Each performer in the three-groups will compress the chest of the manikin on the bed with real-time 5cm,6cm and 7cm feed-back by one accelerometer (U-cpr).We will use two beds [Stryker ST104-747(Transport stretcher®, 760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US) ,Shinchang SB-34p (Transport stretcher® , 850 x 2080 mm,Shinchang Co.,Busan,ROK)]. Each participants will do 6 cycles of chest compression and 1cyle will be 2minutes. Between each cycles, participants will take a rest 5minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chest compression with 5cm feedback | Experimental | Device: Stryker ST104-747, Device: Shinchang SB-34pWe will feedback by one accelerometer (U-cpr). U-cpr is android based smartphone application. |
| chest compression with 6cm feedback | Experimental | Device: Stryker ST104-747, Device: Shinchang SB-34pWe will feedback by one accelerometer(U-cpr). U-cpr is android based smartphone application. |
| chest compression with 7cm feedback | Experimental | Device: Stryker ST104-747, Device: Shinchang SB-34pWe will feedback by one accelerometer(U-cpr). U-cpr is android based smartphone application. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Postgraduates year 1,2,3,4 and Emergency physicians in emergency department
Key exclusion criteria (1 listed)
- Wrist or Low back disease
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 |
|---|---|---|
| Stryker ST104-747Also: Transport stretcher®760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US | Device | chest compression with 5cm feedback, chest compression with 6cm feedback, chest compression with 7cm feedback |
| Shinchang SB-34pAlso: Transport stretcher®, 850 x 2080 mm,Shinchang Co.,Busan,ROK | Device | chest compression with 5cm feedback, chest compression with 6cm feedback, chest compression with 7cm feedback |
Primary outcome
Chest compression depth
Time frame: Within 1day
Primary out come is measured by Resusci Anne Modular System Skill Reporter manikin (9.89 kg, Laerdal Medical, Orpington, UK)
1 secondary outcome
Chest compression rate
Time frame: Within 1day
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 21 Mar 2014.
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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.
Sang hyun Lee, M.D principal investigator
Hanyang University Seoul Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stryker ST104-747 and Shinchang SB-34p in people with Cardiac Arrest, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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 1 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 21 Mar 2014. 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 South Korea. 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?
Chest compression depth (time frame: Within 1day). 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 21 Mar 2014.