UMIN-CTR Clinical Trial

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
Email	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
Email	41239258@hama-med.ac.jp

Sponsor
Institute	Department of Emergency & Disaster Medicine, Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038926