UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036023 |
|---|---|
| Receipt number | R000038926 |
| Scientific Title | The potential of manual chest compression on moving stretcher with a foothold during cardiopulmonary resuscitation. |
| Date of disclosure of the study information | 2019/02/27 |
| Last modified on | 2020/02/13 13:50:38 |
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Basic information
Public title
The potential of manual chest compression on moving stretcher with a foothold during cardiopulmonary resuscitation.
Acronym
The potential of manual chest compression on moving stretcher with a foothold during cardiopulmonary resuscitation.
Scientific Title
The potential of manual chest compression on moving stretcher with a foothold during cardiopulmonary resuscitation.
Scientific Title:Acronym
The potential of manual chest compression on moving stretcher with a foothold during cardiopulmonary resuscitation.
Region
| Japan |
Condition
Condition
The staffs of Hamamatsu University School of Medicine
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate rescuer's fatigue of manual chest compression on moving stretcher with or without a foothold during cardiopulmonary resuscitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of modified Borg scale of rescuers after chest compression while a stretcher moves with or without a foothold.
Key secondary outcomes
1. The relationship between the height, the weight, the length of the legs, the length of the arms and the sole size, and the modified Borg scale of the rescures.
2. The changes in the heart rate, the blood pressure, oxgen saturation of arterial blood, the fraction of the effective chest compression after two trials.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The rescuers perform two methods of the chest compressions for one day.
We measure the rescure's height, weight, the length of the legs, the length of the arms and the sole size before the trials. We record the modified Borg scale of the rescures, the changes in the heart rate, the blood pressure, oxgen saturation of arterial blood before and after each two trials. We use a CPR manikin(Little Anne; Laerdal Medical) laid on the stretcher, and a sensor sheet for evaluating chest compression (Shinnosuke-Kun;Sumitomo Riko Company). The sensor sheet is attached on the lower half of its sternum. The sensor sheet will be shielded from the rescuers during the trials. For the trials, we perform tracheal intubation to the manikin. When the stretcher is moving at a speed of 1.0 m/s, the rescures perform chest compression aside of the stretcher for 2 minutes(WA, Interventions 1). The position of the knees places in the same height of the stretcher. After that, the vital signs and the modified Borg scale are measured. After enough rest, we measure their vital signs at rest again. As the next trial, the rescures perform chest compression for two minutes standing on the footholds of the stretcher when the stretcher moves at the same speed(FO, Intervention 2). Each rescure performs WA and FO in random order. In the two trials, we record the compression depths, chest wall recoil, the chest compression rate, duty cycle(the ratio of the compression time in the total time of one chest compression), hand position, the number of compression. We use the modified Borg scale for the estimation of rescuers' fatigue after each two trial.
Interventions/Control_2
As described above
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy medical workers competent in basic life support
Key exclusion criteria
person who has with the heart disease or the orthopedics disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeji |
| Middle name | |
| Last name | Saito |
Organization
Hamamatsu University School of Medicine
Division name
Department of Emergency & Disaster Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL
053-435-2759
tjsaitoh@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Nakashima |
Organization
Hamamatsu University School of Medicine
Division name
Department of Emergency & Disaster Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
TEL
053-435-2759
Homepage URL
41239258@hama-med.ac.jp
Sponsor or person
Institute
Department of Emergency & Disaster Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Emergency & Disaster Medicine, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine Local Ethics Committee
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel
053-435-2111
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
浜松医科大学(静岡県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038926
