UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048559 |
|---|---|
| Receipt number | R000055327 |
| Scientific Title | Effects of temperature management protocol using pre-post warming and clinical judgment algorithms in the operating room |
| Date of disclosure of the study information | 2022/08/05 |
| Last modified on | 2024/03/11 23:38:22 |
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Basic information
Public title
Effects of pre-post warming in the operating room and clarification and unification of clinical judgments on temperature management
Acronym
Effects of pre-post warming in the operating room and clarification and unification of clinical judgments on temperature management
Scientific Title
Effects of temperature management protocol using pre-post warming and clinical judgment algorithms in the operating room
Scientific Title:Acronym
Effects of temperature management protocol using pre-post warming and clinical judgment algorithms in the operating room
Region
| Japan |
Condition
Condition
Laparoscopic gastrectomy or enterectomy
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will compare the temperature management protocol including pre-post warming and conventional temperature management, and clarify the effect on perioperative temperature management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature from the time of entering the operating room to the time of leaving the room
Key secondary outcomes
presence or absence of shivering
heart rate
average blood pressure
amount of blood loss
presence or absence of pressure ulcers
presence of hot or cold
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
Forced-air warming with an underbody blanket before and after surgery
Interventions/Control_2
Forced-air warming with an overbody blanket before and after surgery
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.over 20 years old
2.American Society of Anesthesiologists physical status 1 or 2
3.Persons whose consent has been obtained by signing a consent form by the patient or a surrogate
Key exclusion criteria
1.robot-assisted surgery
2.emergency surgery
3.Patients with known or suspected malignant hyperthermia
4.American Society of Anesthesiologists physical status 3 or higher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Wakisaka |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Nursing, Adult Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, Japan
TEL
0534352828
wakisaka@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirona |
| Middle name | |
| Last name | Ishihara |
Organization
Seirei Mikatahara General Hospital
Division name
nursing department
Zip code
433-8558
Address
3453 Mikatahara-cho, Kita-ku, Hamamatsu City, Shizuoka, Japan
TEL
0534361251
Homepage URL
M20015@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seirei Mikatahara General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka, Japan
Tel
0534352680
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
聖隷三方原病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 05 | 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
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
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055327
