Cardiopulmonary Resuscitation, Simulation TrainingNCT03124290
The Effect of Attention Distractor on the Quality of Chest Compression
A study testing paced auditory serial addition test (PASAT) in people with Cardiopulmonary Resuscitation, Simulation Training, run by Inje University at 1 site in South Korea.
Trial summary
The investigators plan to investigate the effect of attention distractor on the quality of chest compression during cardiopulmonary resuscitation. For this, a simulated study with Manikin is performed and the paced auditory serial addition test (PASAT) is used for distracting performer's attention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Simulation Training
- What is being tested?
- paced auditory serial addition test (PASAT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2017to 20 May 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers who completed basic life support course among medical personnel (doctors, nurses, paramedics) working in a university hospital
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Attention Distractor During Cardiopulmonary Resuscitation on the Quality of Chest Compression: Randomized Crossover Trial With Simulated Situation
The investigators plan to investigate the effect of attention distractor on the quality of chest compression during cardiopulmonary resuscitation. For this, a simulated study with Manikin is performed and the paced auditory serial addition test (PASAT) is used for distracting performer's attention.
- Being tested
- paced auditory serial addition test (PASAT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paced auditory serial addition test (PASAT)Other
A number between 1 to 9 is called every three seconds through a speaker, and the performer calculates the last two numbers and shouts the answer.
| Study group | Role | What they receive |
|---|---|---|
| CPR with attention distraction first | Other | First, they perform two-minute chest compressions with conducting the PASAT. After 20 mins' rest, they perform two-minute chest compressions without conducting the PASAT. Receives: Other: paced auditory serial addition test (PASAT) |
| CPR without attention distraction first | Other | First, they perform two-minute chest compressions without conducting the PASAT. After 20 mins' rest, they perform two-minute chest compressions with conducting the PASAT. Receives: Other: paced auditory serial addition test (PASAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate compression rate
the percentage of chest compression with adequate rate (100-120 per minute) during two-minute chest compression. Formula(%)=number of adequate chest compressions (rate:100-120/min) x 100 / number of all chest compressions during two minutes
Measured: two minutes
Secondary outcomes (5)
adequate compression depth
the percentage of chest compression with adequate depth (5-6cm) during two-minute chest compression. Formula(%)= number of adequate chest compressions(depth=5-6cm)x 100 / all chest compressions during two minutes
Measured: two minutes
adequate chest recoil
the percentage of chest compression with adequate chest recoil during two-minute chest compression. Formula(%)=number of adequate chest recoils(automatically measured with simulator) x 100/ number of all chest compressions during two minutes
Measured: two minutes
mean compression rate
Average of compression rate during two-minute chest compression. The scale for this outome is 'number per minute'.
Measured: two minutes
mean compression depth
Average of compression depth during two-minute chest compression. The scale for this outcome is 'cm'.
Measured: two minutes
Subjective difficulty
Each performer rate the subjective difficulties of two arms with the 100mm VAS (0: very easy, 100: very difficult)
Measured: Two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start27 Apr 2017
- Primary completion14 May 2017
- Study completion20 May 2017
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 Cardiopulmonary Resuscitation, Simulation TrainingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Min Park, Inje University
- Investigators
- Joon Min Park, Principal investigator, Inje University Ilsan Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124290
- Sponsor's protocol ID
- 2017-04-007
- Status last verified
- May 2017
- First submitted
- 18 Apr 2017
- Last updated
- 23 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee K, Kim MJ, Park J, Park JM, Kim KH, Shin DW, Kim H, Jeon W, Kim H. The effect of distraction by dual work on a CPR practitioner's efficiency in chest compression: A randomized controlled simulation study. Medicine (Baltimore). 2017 Oct;96(43):e8268. doi: 10.1097/MD.0000000000008268.
PubMed 29068995
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Attention Distractor During Cardiopulmonary Resuscitation on the Quality of Chest Compression: Randomized Crossover Trial With Simulated Situation
- ClinicalTrials.gov ID
- NCT03124290
- Acronym / sponsor ID
- 2017-04-007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 14 May 2017 (actual)
- Study completion
- 20 May 2017 (actual)
- First posted
- 21 Apr 2017 (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.
The investigators plan to investigate the effect of attention distractor on the quality of chest compression during cardiopulmonary resuscitation. For this, a simulated study with Manikin is performed and the paced auditory serial addition test (PASAT) is used for distracting performer's attention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPR with attention distraction first | Other | Other: paced auditory serial addition test (PASAT)First, they perform two-minute chest compressions with conducting the PASAT. After 20 mins' rest, they perform two-minute chest compressions without conducting the PASAT. |
| CPR without attention distraction first | Other | Other: paced auditory serial addition test (PASAT)First, they perform two-minute chest compressions without conducting the PASAT. After 20 mins' rest, they perform two-minute chest compressions with conducting the PASAT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers who completed basic life support course among medical personnel (doctors, nurses, paramedics) working in a university hospital
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| paced auditory serial addition test (PASAT)A number between 1 to 9 is called every three seconds through a speaker, and the performer calculates the last two numbers and shouts the answer. | Other | CPR with attention distraction first, CPR without attention distraction first |
Primary outcome
adequate compression rate
Time frame: two minutes
the percentage of chest compression with adequate rate (100-120 per minute) during two-minute chest compression. Formula(%)=number of adequate chest compressions (rate:100-120/min) x 100 / number of all chest compressions during two minutes
5 secondary outcomes
adequate compression depth
Time frame: two minutes
adequate chest recoil
Time frame: two minutes
mean compression rate
Time frame: two minutes
mean compression depth
Time frame: two minutes
Subjective difficulty
Time frame: Two minutes
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 23 May 2017.
- Derived from this study: PubMed 29068995Lee K, Kim MJ, Park J, Park JM, Kim KH, Shin DW, Kim H, Jeon W, Kim H. The effect of distraction by dual work on a CPR practitioner's efficiency in chest compression: A randomized controlled simulation study. Medicine (Baltimore). 2017 Oct;96(43):e8268. doi: 10.1097/MD.0000000000008268.
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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.
Joon Min Park principal investigator
Inje University Ilsan Paik 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 paced auditory serial addition test (PASAT) in people with Cardiopulmonary Resuscitation, Simulation Training, run by Inje University 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 23 May 2017. 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?
adequate compression rate (time frame: two minutes). 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 NCT03124290, 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 23 May 2017.