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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

South Korea1 site
  • Hanyang University Seoul Hospital

    Seoul, 133792

Other trials in South Korea

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 groups in NCT02043028
Study groupRoleWhat they receive
Group 1ExperimentalParticipants 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 2ExperimentalParticipants 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.

  1. 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)
  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.

  1. First posted23 Jan 2014 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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)
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

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.

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