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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036826
Receipt No. 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 2019/09/30

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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
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 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
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.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


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