UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057289 |
|---|---|
| Receipt number | R000065479 |
| Scientific Title | A prospective study to evaluate the safety of anesthesia maintenance by a remote anesthesiologist with assistance from an advanced perioperative nurse. |
| Date of disclosure of the study information | 2025/03/15 |
| Last modified on | 2026/03/17 13:19:21 |
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Basic information
Public title
Evaluation of the safety of anesthesia maintenance by a remote anesthesiologist and an advanced perioperative nurse.
Acronym
Evaluation of the safety of remote anesthesia by an anesthesiologist and an advanced perioperative nurse.
Scientific Title
A prospective study to evaluate the safety of anesthesia maintenance by a remote anesthesiologist with assistance from an advanced perioperative nurse.
Scientific Title:Acronym
Evaluation of the safety of remote anesthesia maintenance by an anesthesiologist and an advanced perioperative nurse: A prospective study.
Region
| Japan |
Condition
Condition
Surgery under anesthesiologist management
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the safety of anesthesia maintenance by a remote anesthesiologist with assistance from an advanced perioperative nurse
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Remote anesthesia discontinuation rate ( = number of discontinuation cases after the initiation of remote anesthesia / number of cases performed)
Key secondary outcomes
Frequency, duration, and details of communication failures
Reasons and frequency of calling the on-site anesthesiologist
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Remote anesthesia maintenance
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endoscopic surgery, superficial surgery, and orthopedic surgery under anesthesiologist management performed in the operating room
ASA-PS 1 or 2
Patients aged 18 years and older at the time of consent acquisition
Patients who have received adequate explanation regarding their participation in this study and have provided written informed consent voluntarily
Key exclusion criteria
Patients scheduled for single-lung ventilation during surgery
Patients deemed unsuitable for participation by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryuki |
| Middle name | |
| Last name | Takaki |
Organization
Chubu Tokushukai Hospital
Division name
Department of anesthesiology
Zip code
901-2393
Address
801 Higa, Kitanakagusuku, Okinawa-ken
TEL
098-932-1110
ryuki.takaki218@gmail.com
Public contact
Name of contact person
| 1st name | Ryuki |
| Middle name | |
| Last name | Takaki |
Organization
Chubu Tokushukai Hospital
Division name
Department of anesthesiology
Zip code
901-2393
Address
801 Higa, Kitanakagusuku, Okinawa-ken
TEL
098-932-1110
Homepage URL
ryuki.takaki218@gmail.com
Sponsor or person
Institute
Chubu Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
03-3263-4801
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
| 2025 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 03 | Month | 14 | Day |
Last modified on
| 2026 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065479
