UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056257 |
|---|---|
| Receipt number | R000058464 |
| Scientific Title | The analysis of incidence and factors of aspiration pneumonia after general anesthesia: a single center retrospective study |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2025/10/19 21:26:21 |
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Basic information
Public title
The analysis of incidence and factors of aspiration pneumonia after general anesthesia: a single center retrospective study
Acronym
The analysis of incidence and factors of aspiration pneumonia after general anesthesia: a single center retrospective study
Scientific Title
The analysis of incidence and factors of aspiration pneumonia after general anesthesia: a single center retrospective study
Scientific Title:Acronym
The analysis of incidence and factors of aspiration pneumonia after general anesthesia: a single center retrospective study
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Pneumology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of postoperative aspiration pneumonia in the patients who received surgery under general anesthesia by using receipt data, electronic medical records, and anesthesia records retrospectively.
Basic objectives2
Others
Basic objectives -Others
To investigate the risk factors of postoperative aspiration pneumonia in the patients who received surgery under general anesthesia by using receipt data, electronic medical records, and anesthesia records retrospectively.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative aspiration pneumonia
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
Patients who underwent general anesthesia for surgery in our institution between from January 1, 2017 to December 31, 2021
Key exclusion criteria
1) Patients who already have received tracheal intubation, tracheostomy, or laryngectomy at the start of general anesthesia
2) Patients who underwent pharyngeal or laryngeal surgery
3) Patients who underwent intraoperative tracheostomy or laryngectomy
4) Patients who already have diagnosed as aspiration pneumonia at the start of general anesthesia
5) Patients less than 18 years old
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto City, Nagano
TEL
0263-37-2670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto City, Nagano
TEL
0263-37-2670
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Nagano
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2024 | Year | 11 | Month | 25 | 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
15713
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
| 2022 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the incidence, timing of onset and diagnosis, and duration of treatment about postoperative aspiration pneumonia during from the day of surgery to post operative day 7 or discharge from the hospital in patients who underwent surgery under general anesthesia. The diagnosis of aspiration pneumonia is based on a combination of receipt data and electronic medical record about diagnosis names, radiographic imaging examinations, and the use of antimicrobial drugs. In addition, the electronic medical record and anesthesia record is used to examine the patient's perioperative information and anesthesia record to determine risk factors of aspiration pneumonia.
Management information
Registered date
| 2024 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058464
