UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033734 |
|---|---|
| Receipt number | R000036807 |
| Scientific Title | Influence of lithotomy position under anesthesia on tissue blood volume and oxygenation in lower limbs |
| Date of disclosure of the study information | 2018/08/13 |
| Last modified on | 2023/01/26 10:58:47 |
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Basic information
Public title
Influence of lithotomy position under anesthesia on tissue blood volume and oxygenation in lower limbs
Acronym
Circulation change in lower limbs in the lithotomy position
Scientific Title
Influence of lithotomy position under anesthesia on tissue blood volume and oxygenation in lower limbs
Scientific Title:Acronym
Circulation change in lower limbs in the lithotomy position
Region
| Japan |
Condition
Condition
Indications for operation in the lithotomy position
Classification by specialty
| Obstetrics and Gynecology | Urology | Anesthesiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We reveal the effect of lithotomy position under anesthesia on tissue circulation in the lower limmb
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of lower limb blood volume measured by near infrared spectroscopy before and after the lithotomy position
Key secondary outcomes
Changes in cardiorespiratory parameters before and after the lithotomy position
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients scheduled for surgery at the lithotomy position who have no systemic complications or mild complications.
Key exclusion criteria
Patients with severe systemic complications.
Patients who are prone to tape rash in daily life
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Matsuda |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Ohyaguchi Kamichou, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
matsuda.miho@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Matsuda |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Ohyaguchi Kamichou, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
matsuda.miho@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine, Department of Anesthesiology
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
Nihon University School of Medicine
Address
30-1, Ohyaguchi Kamichou, Itabashi-ku, Tokyo, Japan
Tel
0339728111
matsuda.miho@nihon-u.ac.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
| 2018 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
http://
Publication of results
Unpublished
Result
URL related to results and publications
http://
Number of participants that the trial has enrolled
35
Results
Data were obtained for a total of 24 patients. total-Hb, nTHI and TOI changes at 60 minutes from the lithotomy pisition were +3.09 micromol/L, +0.083 a.u. and +2.25 %, all significantly elevated (p < 0.05). The results of the regression analysis showed no factors significantly associated with the increase in each measure.
Results date posted
| 2023 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 24 patients, 18 were men and 6 were women. Preoperative complications were hypertension in 14 and diabetes in 6. Anesthesia methods were inhalation anesthesia in 23 patients and TIVA in 1 patient.
Participant flow
Adult patients undergoing scheduled surgery in the lithotomy position under general anesthesia at our hospital from April 2018 to December 2019 were included in the study. After explaining this study to the patients, the study was conducted on those who fully understood the study and gave their written consent.
Adverse events
none
Outcome measures
Total-Hb, nTHI, and TOI of the thigh, as measured by NIRS, were recorded up to 60 min after the lithotomy position
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
1.Study design : observational study (case-control study)
2.Participants : Adult patients scheduled for surgery under anesthesia at the lithotomy position
3.Observational endpoint : changes in the tissue blood volume in the lower limb evaluated by NIRS before and after the lithotomy position
Management information
Registered date
| 2018 | Year | 08 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036807
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