UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057710 |
|---|---|
| Receipt number | R000065942 |
| Scientific Title | A study of endotracheal temperature changes and tube protection during thyroid surgery |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/04/24 16:08:29 |
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Basic information
Public title
A study of endotracheal temperature and tube protection
Acronym
Endotracheal tube protection study
Scientific Title
A study of endotracheal temperature changes and tube protection during thyroid surgery
Scientific Title:Acronym
Endotracheal temperature changes and tube protection during thyroid surgery
Region
| Japan |
Condition
Condition
Thyroid diseases
Classification by specialty
| Endocrine surgery | Oto-rhino-laryngology | Anesthesiology |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate endotracheal tube temperature changes during thyroid surgery. We also examine whether our specially designed tube stand prevents endotracheal tube kink in patients undergoing thyroid surgery and whether the modification precludes ventilatory derangement due to tube warming during the surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endotracheal tube temperature changes during thyroid surgery
Key secondary outcomes
To evaluate whether our specially designed tube stand prevents the endotracheal tube kink in patients undergoing thyroid surgery and whether the modification precludes ventilatory derangement due to tube warming during the surgery.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing thyroid surgery
Key exclusion criteria
Patients without informed consent
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kinoshita |
Organization
Hamamatsu University School of Medicine
Division name
Departments of Anesthesiology and Intensive Care
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2286
hkinoshi@krc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kinoshita |
Organization
Hamamatsu University School of Medicine
Division name
Departments of Anesthesiology and Intensive Care
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2286
Homepage URL
hkinoshi@krc.biglobe.ne.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Seirei Mikatahara General Hospital
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu, Shizuoka
Tel
053-436-1251
hkinoshi@krc.biglobe.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23-77
Org. issuing International ID_1
Seirei Mikatahara General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | 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
5
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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065942
