UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036826 |
|---|---|
| Receipt number | R000041957 |
| Scientific Title | Effects of Post-operative temperature management care protocol on Postoperative Body Temperature Distribution |
| Date of disclosure of the study information | 2019/05/23 |
| Last modified on | 2021/12/20 16:55:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Post-operative temperature management care protocol on Postoperative Body Temperature Distribution
Acronym
Effects of Post-operative temperature management care protocol on Postoperative Body Temperature Distribution
Scientific Title
Effects of Post-operative temperature management care protocol on Postoperative Body Temperature Distribution
Scientific Title:Acronym
Effects of Post-operative temperature management care protocol on Postoperative Body Temperature Distribution
Region
| Japan |
Condition
Condition
Perioperative patients
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to test a hypothesis that postoperative temperature management care protocol reduces the hypothermia improving the peripheral circulation and the patient's comfort immediately after major abdominal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Temperature measurements will be started prior to induction of general anesthesia and continued up to 12 hours after arrival at the ward. The measurement values will be obtained at various perioperative time points: prior to induction of general anesthesia, during operation, end of surgery, extubation of tracheal tube, leaving of operation room, arrival at the ward, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50minutes after arrival at the ward, and every one hour after arrival at the ward.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Routine care: Patients in control group were covered with cotton blankets immediately after arrival at the surgical wards.
Interventions/Control_2
During the postoperative period, the intervention group will receive a series of postoperative temperature management care protocol.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
The inclusion criteria are patients undergoing laparotomy surgery.
Key exclusion criteria
Exclusion criteria are: patients with metabolic diseases, patients with peripheral vascular disease, patients with serious preoperative and intraoperative complications, patients receiving continuous catecholamine infusion.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Kameda |
Organization
Graduate School of Nursing, Chiba University
Division name
Faculty Doctoral student of Frontier Practice Nursing
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
TEL
+81-43-226-2408
norihiro0430@chiba-u.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Kameda |
Organization
Graduate School of Nursing, Chiba University
Division name
Faculty Doctoral student of Frontier Practice Nursing
Zip code
260-8672
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
TEL
+81-43-226-2408
Homepage URL
norihiro0430@chiba-u.jp
Sponsor or person
Institute
Graduate School of Nursing, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Graduate School of Nursing, Chiba University, Chiba, Japan
Address
1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba, Japan
Tel
+81-43-226-2382
tae5667@office.chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
54
Results
Temperature gaps calculated as the difference between core and skin temperatures were similar value in the control and intervention groups at the end of surgery. However, temperature gap in the intervention group, decreased within 3 hour after arrival at the ward, and remained lower than the control group. The VAS score of postoperative thermal discomfort was significantly smaller in the intervention group than the control group suggesting achievement of higher comfortableness of the intervention.
Results date posted
| 2021 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients underwent hepatobiliary pancreatic surgeries. No significant differences were observed between the control and the intervention groups. Although the core temperatures significantly decreased in both groups during anesthesia and surgery, no differences between the groups were found in all body temperatures before and during surgery.
Participant flow
Laparotomy patients who were candidates for research (n=59)
Consented to study participation (n=56)
Intervention group (n=28) and Control group: routine care (n=28)
Patients who have completed the research was 27 patients, respectively.
Adverse events
nothing
Outcome measures
Transition of body temperatures
Thermal discomfort and wound pain
Occurrence of shivering
Incidence of SSI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | 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
| 2019 | Year | 05 | Month | 23 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041957
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
