UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060182 |
|---|---|
| Receipt number | R000068830 |
| Scientific Title | Transfer of male patients from the dental chair to the floor by female staff for cardiopulmonary resuscitation: a randomized study |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/23 15:08:42 |
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Basic information
Public title
Transfer of male patients from the dental chair to the floor by female staff for cardiopulmonary resuscitation
Acronym
Transfer of male patients from the dental chair to the floor by female staff for cardiopulmonary resuscitation: a randomized study
Scientific Title
Transfer of male patients from the dental chair to the floor by female staff for cardiopulmonary resuscitation: a randomized study
Scientific Title:Acronym
Transfer of male patients from the dental chair to the floor by female staff for cardiopulmonary resuscitation: a randomized study
Region
| Japan |
Condition
Condition
A patient in cardiac arrest seated in the dental chair
Classification by specialty
| Oral surgery | Emergency medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In cases of cardiac arrest in dental patients, it is often recommended to move the patient to the floor to facilitate effective chest compressions. However, most dental clinics in Japan have a limited staff, often predominantly female, with unique challenges in transferring patients, especially overweight male patients. These challenges include confined space, limited personnel, obstructive equipment, and the physical size of the patient. This study examined several factors that affect female staff members ability to transfer male patients from a dental chair to the floor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A randomized crossover study was conducted involving four male and nine female rescuers using two types of dental chairs (with and without side tables). Variables such as the number of female rescuers, transfer time, changes in vital signs, and perceived fatigue were assessed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A female staff member playing the role of a male patient moves from dental chairs to the floor.
Interventions/Control_2
A female staff member playing the role of a male patient moves from two types of dental chairs to the floor.
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
| 37 | years-old | <= |
Age-upper limit
| 51 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient role volunteer
Key exclusion criteria
Volunteers with a history of orthopedic conditions
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hitosugi |
Organization
Nihon University
Division name
Department of Anesthesiology
Zip code
101-8310
Address
1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
0332198140
hitosugi.takashi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hitosugi |
Organization
Nihon University
Division name
Department of Anesthesiology
Zip code
101-8310
Address
1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL
0332198140
Homepage URL
hitosugi.takashi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Takashi Hitosugi
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University
Address
1-8-13, Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
Tel
0332198140
hitosugi.takashi@nihon-u.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
Tokyo
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 23 | 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
13
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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068830
