Cardiac ArrestNCT02043028
Kneeling Posture With a Kneeling Stool During Cardiopulmonary Resuscitation in Hospital
A study testing Chest compression with a step stool and Chest compression with a kneeling stool in people with Cardiac Arrest, run by Hanyang University at 1 site in South Korea.
Trial summary
To perform chest compression (CC) in the kneeling posture in hospital, we designed a stage with stairs, named the 'kneeling stool', on which a CC performer kneels beside a patient on a bed.This work is the validation study to demonstrate that the kneeling stool could be used for high quality hospital cardiopulmonary… 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?
- Chest compression with a step stool and Chest compression with a kneeling stool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Aug 2013
- 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
- Doctors and nurses working at emergency department
- American Heart Association Basic Life Support (AHA BLS) provider certification
Who cannot join
- Heart, wrist, or low back disease or who were pregnant were excluded
Trial locations and contacts
1 site in 1 country.
About this study
To perform chest compression (CC) in the kneeling posture in hospital, we designed a stage with stairs, named the 'kneeling stool', on which a CC performer kneels beside a patient on a bed.This work is the validation study to demonstrate that the kneeling stool could be used for high quality hospital cardiopulmonary resuscitation (CPR) with the kneeling posture. We hypothesized that the quality of chest compression with a kneeling posture using the kneeling stool is equal to or superior to CC with a standing posture using the height adjustment mechanism of the bed.
Read the detailed description
We designed and implemented the kneeling stool to perform CPR with the kneeling posture for a patient on a bed. The frame is constructed of an aluminum alloy. The size is 570 mm (width) x 598 mm (depth) x 600 mm (height). The weight is 9.3 kg, which is easily moved as needed. For easy rotation between rescuers, a step plate was inserted. To prevent pain to the knees of the kneeling CC performer, a 40mmthick sponge cushion was placed on the top plate and fixed to the frame.
A standard hospital bed frame (Transport stretcher®, 760 x2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, USA), a foam mattress (660 x 920 x 80 mm, soft foam with polyurethane coverage, Stryker Co., USA), a backboard (450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea), and a step stool (395 x 450 x 410 mm, Gunica Co., Gyeongsangnam-do, Korea) were used in the experiment. A Resusci Annie Modular System Skill Reporter® manikin (Laerdal Medical, Orpington, UK) was used to perform CPR in the evaluations. We added weight to the manikin to equal 34 kg for simulating the upper body weight of an adult human as in a previous study.
Data collection The participants were divided into two groups by random drawing. Each performer in the first group knelt on the kneeling stool beside the manikin on a bed and compressed the chest of the manikin (CCs with a kneeling posture, PK).Each performer in the second group stood on a step stool beside the manikin on a bed and compressed the chest of the manikin (CCs with a standing posture, PS). When the performer stood beside the manikin on a bed, the height of the manikin's back was adjusted in height to the knee level of the provider using the step stool and the bed height adjustment mechanism. All the participants performed continuous CCs for 5 minutes without audio-visual feedback. After 2 weeks, the posture used for the CCs by each group was changed. Each participant recorded his/her fatigue and pain levels on a visual analogue scale (VAS, score 0 indicates "no pain and fatigue" and score 10 indicates "unbearable pain and fatigue") for each minute during 5 minutes of CCs. After conclusion of the experiment, the participants selected a preferred CC posture in terms of the safety and the quality of the CCs.
- Conditions
- Cardiac Arrest
- Being tested
- Chest compression with a step stool, Chest compression with a kneeling stool
- Keywords
- Cardiopulmonary resuscitation, Chest compression, Advanced cardiac life support, Posture
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest compression with a step stoolDevice
Participants compress the chest of a manikin with a standing posture using a step stool during 5 minutes
Chest compression with a kneeling stoolDevice
Participants compress the chest of a manikin with kneeling posture using a kneeling stool during 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants compress the chest of a manikin with kneeling posture using a kneeling stool for chest compression posture during 5 minutes
2 weeks later, They perform the chest compression with standing posture using a step stool during 5 minutes Receives: Device: Chest compression with a step stool; Device: Chest compression with a kneeling stool |
| Group 2 | Experimental | Participants compress the chest of a manikin with a standing posture using a step stool for chest compression posture during 5 minutes
2 weeks later, They perform the chest compression with a kneeling posture using a kneeling stool stool and bed height adjustment during 5 minutes Receives: Device: Chest compression with a step stool; Device: Chest compression with a kneeling stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest compression parameter
Chest compression depth and rate Accuracy of chest compression depth at least 5cm Incomplete chest recoil
Measured: one day
Secondary outcomes (1)
Visual analog scale(VAS) score of the overall fatigue and pain during chest compression
the VAS score ( 0, no fatigue pain to 10, unbearable) for the fatigue and pain during and after chest compression.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 2013
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaehoon Oh, Hanyang University
- Investigators
- Jaehoon Oh, M.D., Principal investigator, Department of emergency medicine, college of medicine, Hanyang university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043028
- Sponsor's protocol ID
- Kneeling Posture
- Other IDs
- University of Ulsan 2013-0141
- Status last verified
- Mar 2014
- First submitted
- 21 Jan 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kneeling Posture With a Kneeling Stool During Cardiopulmonary Resuscitation in Hospital
- ClinicalTrials.gov ID
- NCT02043028
- Acronym / sponsor ID
- Kneeling Posture
- Conditions
- Cardiac Arrest
- Keywords
- Cardiopulmonary resuscitation, Chest compression, Advanced cardiac life support, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Jan 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.
To perform chest compression (CC) in the kneeling posture in hospital, we designed a stage with stairs, named the 'kneeling stool', on which a CC performer kneels beside a patient on a bed.This work is the validation study to demonstrate that the kneeling stool could be used for high quality hospital cardiopulmonary resuscitation (CPR) with the kneeling posture. We hypothesized that the quality of chest compression with a kneeling posture using the kneeling stool is equal to or superior to CC with a standing posture using the height adjustment mechanism of the bed.
Detailed description
We designed and implemented the kneeling stool to perform CPR with the kneeling posture for a patient on a bed. The frame is constructed of an aluminum alloy. The size is 570 mm (width) x 598 mm (depth) x 600 mm (height). The weight is 9.3 kg, which is easily moved as needed. For easy rotation between rescuers, a step plate was inserted. To prevent pain to the knees of the kneeling CC performer, a 40mmthick sponge cushion was placed on the top plate and fixed to the frame.
A standard hospital bed frame (Transport stretcher®, 760 x2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, USA), a foam mattress (660 x 920 x 80 mm, soft foam with polyurethane coverage, Stryker Co., USA), a backboard (450 ×600 ×10 mm, 3 kg Lifeline Plastic, Sung Shim Medical Co., Bucheon, Korea), and a step stool (395 x 450 x 410 mm, Gunica Co., Gyeongsangnam-do, Korea) were used in the experiment. A Resusci Annie Modular System Skill Reporter® manikin (Laerdal Medical, Orpington, UK) was used to perform CPR in the evaluations. We added weight to the manikin to equal 34 kg for simulating the upper body weight of an adult human as in a previous study.
Data collection The participants were divided into two groups by random drawing. Each performer in the first group knelt on the kneeling stool beside the manikin on a bed and compressed the chest of the manikin (CCs with a kneeling posture, PK).Each performer in the second group stood on a step stool beside the manikin on a bed and compressed the chest of the manikin (CCs with a standing posture, PS). When the performer stood beside the manikin on a bed, the height of the manikin's back was adjusted in height to the knee level of the provider using the step stool and the bed height adjustment mechanism. All the participants performed continuous CCs for 5 minutes without audio-visual feedback. After 2 weeks, the posture used for the CCs by each group was changed. Each participant recorded his/her fatigue and pain levels on a visual analogue scale (VAS, score 0 indicates "no pain and fatigue" and score 10 indicates "unbearable pain and fatigue") for each minute during 5 minutes of CCs. After conclusion of the experiment, the participants selected a preferred CC posture in terms of the safety and the quality of the CCs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Chest compression with a step stool, Device: Chest compression with a kneeling stoolParticipants compress the chest of a manikin with kneeling posture using a kneeling stool for chest compression posture during 5 minutes 2 weeks later, They perform the chest compression with standing posture using a step stool during 5 minutes |
| Group 2 | Experimental | Device: Chest compression with a step stool, Device: Chest compression with a kneeling stoolParticipants compress the chest of a manikin with a standing posture using a step stool for chest compression posture during 5 minutes 2 weeks later, They perform the chest compression with a kneeling posture using a kneeling stool stool and bed height adjustment during 5 minutes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Doctors and nurses working at emergency department
- American Heart Association Basic Life Support (AHA BLS) provider certification
Key exclusion criteria (1 listed)
- Heart, wrist, or low back disease or who were pregnant were excluded
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 |
|---|---|---|
| Chest compression with a step stoolParticipants compress the chest of a manikin with a standing posture using a step stool during 5 minutes | Device | Group 1, Group 2 |
| Chest compression with a kneeling stoolParticipants compress the chest of a manikin with kneeling posture using a kneeling stool during 5 minutes | Device | Group 1, Group 2 |
Primary outcome
Chest compression parameter
Time frame: one day
Chest compression depth and rate Accuracy of chest compression depth at least 5cm Incomplete chest recoil
1 secondary outcome
Visual analog scale(VAS) score of the overall fatigue and pain during chest compression
Time frame: one day
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 18 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.
Jaehoon Oh, M.D. principal investigator
Department of emergency medicine, college of medicine, Hanyang university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest compression with a step stool and Chest compression with a kneeling stool in people with Cardiac Arrest, run by Hanyang 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 2 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 18 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 parameter (time frame: one day). 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 18 Mar 2014.