UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062883 |
|---|---|
| Receipt number | R000072000 |
| Scientific Title | Preoperative Airway Assessment and Changes in Airway Management for Acromegaly: A Single-Center Retrospective Study |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 12:15:04 |
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Basic information
Public title
Preoperative Airway Assessment and Changes in Airway Management for Acromegaly: A Single-Center Retrospective Study
Acronym
Preoperative Airway Assessment and Changes in Airway Management for Acromegaly: A Single-Center Retrospective Study
Scientific Title
Preoperative Airway Assessment and Changes in Airway Management for Acromegaly: A Single-Center Retrospective Study
Scientific Title:Acronym
Preoperative Airway Assessment and Changes in Airway Management for Acromegaly: A Single-Center Retrospective Study
Region
| Japan |
Condition
Condition
Acromegaly
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how the difficulty of endotracheal intubation and the rate of awake intubation selection among patients with acromegaly changed before and after the widespread adoption of video laryngoscopes at our facility.
Basic objectives2
Others
Basic objectives -Others
To determine whether the severity of sleep apnea syndrome assessed during preoperative evaluation for acromegaly and findings on head and neck X-rays are associated with the actual difficulty of intubation, and to identify factors specific to acromegaly that contribute to airway management difficulties.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tracheal Intubation Difficulty, Rate of Awake Intubation
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All adult patients with acromegaly who underwent pituitary tumor resection under general anesthesia at Chiba University Hospital between January 1, 1996, and December 31, 2025
Key exclusion criteria
1) Subjects under the age of 18
2) Individuals who expressed their refusal to participate in this study through the informed consent document
3) Other cases deemed inappropriate by the researchers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamada |
Organization
Chiba University Hospital
Division name
Department of Anesthesiology, Pain and Palliative Care Medicine
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan
TEL
0432227171
tyamada_violine@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamada |
Organization
Chiba university hospital
Division name
Department of Anesthesiology, Pain and Palliative Care Medicine
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan
TEL
0432227171
Homepage URL
tyamada_violine@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-Ku, Chiba 260-8670, Japan
Tel
0432227171
tyamada_violine@yahoo.co.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
| 2026 | Year | 09 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses medical record data through August 9, 2026, for patients who underwent pituitary tumor resection under general anesthesia between January 1, 1996, and December 31, 2025.
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072000
