UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062367 |
|---|---|
| Receipt number | R000071378 |
| Scientific Title | Frequency and Associated Factors of Asymptomatic Transient Bacteremia Following Nasotracheal Intubation: A Multicenter Prospective Study |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 15:32:03 |
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Basic information
Public title
A Study of How Often and Why Germs Briefly and Without Symptoms Enter the Blood During Nasal Tube Placement
Acronym
NB Study
Scientific Title
Frequency and Associated Factors of Asymptomatic Transient Bacteremia Following Nasotracheal Intubation: A Multicenter Prospective Study
Scientific Title:Acronym
FANT Study
Region
| Japan |
Condition
Condition
Patients scheduled to undergo orthognathic surgery (bimaxillary osteotomy or BSSO) under general anesthesia with nasotracheal intubation
Classification by specialty
| Anesthesiology | Oral surgery | Laboratory medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency of bacterial DNA detection in arterial blood before and after nasotracheal intubation following standardized nasal decontamination in patients undergoing orthognathic surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the 16S rRNA gene PCR positivity rate in arterial blood before nasotracheal intubation versus 1 minute after completion of 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
1. Patients aged 18 years or older who are scheduled to undergo orthognathic surgery (bimaxillary osteotomy or mandibular osteotomy) under general anesthesia with nasotracheal intubation
2. Patients from whom written informed consent has been obtained
Key exclusion criteria
1. Patients who require preoperative antimicrobial administration before entering the operating room, such as those at high risk of infective endocarditis
2. Patients who have received antimicrobial therapy within 7 days prior to surgery
3. Patients with overt immunosuppression (e.g., long-term corticosteroid use or ongoing chemotherapy)
4. Patients judged inappropriate for study participation by the attending physician or the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Nagasaki University Hospital
Division name
Department of Dental Anesthesiology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7714
s-tsukimoto@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Nagasaki University Hospital
Division name
Department of dental anesthesiology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-819-7714
Homepage URL
s-tsukimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
長崎大学病院（長崎県）、名古屋市立大学（愛知県）、愛知学院大学（愛知県）、神奈川歯科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations (per protocol Section 4.4): patient background (age, sex, BMI, smoking, ASA-PS, comorbidities, immunosuppression, medications, preoperative infection signs); anesthesia/surgical record (method, procedure, operation/anesthesia time, body temperature, BP, pulse rate, SpO2, perfusion index); nasotracheal intubation information (tube/product, side, attempts, Cormack-Lehane grade, instrument change, epistaxis 4-grade: 0 none / 1 on tube / 2 suction required / 3 packing required, local treatment, prophylactic antimicrobial: agent/dose/timing); specimen time stamps (nasal swab N1 pre-/N2 post-decontamination, radial artery catheter insertion, arterial blood draw #1 baseline/#2 at 1 min after cuff inflation).
Timing: consent and background obtained at pre-operative visit. After anesthesia induction: radial artery catheter, draw #1, nasal N1, 0.025% BZK decontamination, N2. Exactly 1 minute after nasotracheal intubation completion (cuff inflation): draw #2. Post-operative chart review for 1 week: wound infection, osteomyelitis, sensory disturbance, pneumonia, post-operative fever, and any event requiring additional treatment. Common data items: WBC, CRP.
Adverse events: intubation epistaxis (4-grade), blood-draw-related (puncture-site hematoma, pain, suspected infection, hemostasis difficulty); SAE (death, life-threatening, prolonged hospitalization, persistent disability). On discovery of SAE or protocol deviation, the site investigator or head of institution is notified, and the head of institution reports to the ethics review committee.
Specimen/data management: arterial blood specimens are sent to the Department of Microbiology, School of Dentistry, Aichi Gakuin University for bacterial 16S rRNA V3-V4 broad-range PCR and sequencing. Nasal swabs undergo culture identification and log reduction quantification. Case report forms are consolidated at Nagasaki University Hospital, Department of Dental Anesthesiology. Retention: 5 years after study completion.
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071378
