UMIN-CTR Clinical Trial

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
Email	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
Email	norihiro0430@chiba-u.jp

Sponsor
Institute	Graduate School of Nursing, Chiba University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041957