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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name