UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037965 |
|---|---|
| Receipt number | R000042953 |
| Scientific Title | Correlation between preoperative toe perfusion index and redistribution hypothermia during caesarean delivery with spinal anesthesia |
| Date of disclosure of the study information | 2019/09/08 |
| Last modified on | 2021/11/01 17:17:04 |
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Basic information
Public title
Correlation between preoperative toe perfusion index and redistribution hypothermia during caesarean delivery with spinal anesthesia
Acronym
Correlation between preoperative toe perfusion index and redistribution hypothermia during caesarean delivery with spinal anesthesia
Scientific Title
Correlation between preoperative toe perfusion index and redistribution hypothermia during caesarean delivery with spinal anesthesia
Scientific Title:Acronym
Correlation between preoperative toe perfusion index and redistribution hypothermia during caesarean delivery with spinal anesthesia
Region
| Japan |
Condition
Condition
Pregnant women undergoing elective caesarean delivery with spinal anesthesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the correlation between preoperative toe perfusion index and perioperative body temperature change in pregnant women undergoing caesarean delivery with spinal anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between preoperative toe perfusion index and maximum perioperative temporal temperature decrease
Key secondary outcomes
Correlation between preoperative toe perfusion index and intraoperative minimum body temperature, shivering, and thermal comfort scores
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women with healthy (American Society of Anesthesiologists physical status 1-2) and full-term pregnancy (gestational age >= 37 weeks)
Key exclusion criteria
1. unscheduled caesarean delivery
2. Obesity (Body Mass Index >= 40 kg/m2)
3. Preoperative hyperthermia (> 38 degrees Celsius) or preoperative hypothermia (< 36 degrees Celsius)
4. Cardiovascular or cerebrovascular disease
5. Hypothyroidism or hyperthyroidism
6. History of anxiety disorder
7. Difficult to maintain supine position
8. Caesarean delivery with general anesthesia
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kaneko |
Organization
National Hospital Organization (NHO) Nagasaki Medical Center
Division name
Department of Anesthesiology
Zip code
856-8562
Address
2-1001-1, Kubara, Omura, Nagasaki, 856-8562, Japan
TEL
0957-52-3121
syohei1224@gmail.com
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kaneko |
Organization
National Hospital Organization (NHO) Nagasaki Medical Center
Division name
Department of Anesthesiology
Zip code
856-8562
Address
2-1001-1, Kubara, Omura, Nagasaki, 856-8562, Japan
TEL
0957-52-3121
Homepage URL
syohei1224@gmail.com
Sponsor or person
Institute
National Hospital Organization (NHO) Nagasaki Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board at Nagasaki Medical Center
Address
2-1001-1, Kubara, Omura, Nagasaki, 856-8562, Japan
Tel
0957-52-3121
shimada.toshio.jn@mail.hosp.go.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 | 09 | Month | 08 | Day |
Related information
URL releasing protocol
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01470-y
Publication of results
Published
Result
URL related to results and publications
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01470-y
Number of participants that the trial has enrolled
48
Results
Low preoperative toe PI was associated with maternal core temperature decrease during cesarean delivery under spinal anesthesia.
Results date posted
| 2021 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The protocol was followed.
Participant flow
The protocol was followed.
Adverse events
None.
Outcome measures
The protocol was followed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 18 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 05 | Day |
Other
Other related information
A single-center prospective observational study to examine the correlation between preoperative toe perfusion index and perioperative body temperature change in pregnant women undergoing caesarean delivery with spinal anesthesia
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042953
