UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061281 |
|---|---|
| Receipt number | R000069995 |
| Scientific Title | Effects of Device Type and Operator Experience on Nasotracheal Intubation Time |
| Date of disclosure of the study information | 2026/04/16 |
| Last modified on | 2026/04/16 19:18:47 |
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Basic information
Public title
Effects of Device Type and Operator Experience on Nasotracheal Intubation Time
Acronym
Effects of Device Type and Operator Experience on Nasotracheal Intubation Time
Scientific Title
Effects of Device Type and Operator Experience on Nasotracheal Intubation Time
Scientific Title:Acronym
Effects of Device Type and Operator Experience on Nasotracheal Intubation Time
Region
| Japan |
Condition
Condition
Patients undergoing dental and oral and maxillofacial surgery under general anesthesia in whom nasotracheal intubation was clinically indicated
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively compare intubation time among three devices - video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes - when used as the first line device for nasotracheal intubation in adult patients undergoing dental and oral and maxillofacial surgery under general anesthesia. In addition, the study will evaluate the association of device type with complications, including bleeding and postoperative hoarseness, as well as operator experience. Currently, there are no clearly established criteria for device selection in nasotracheal intubation, and the choice is largely dependent on operator experience and institutional practice. This may result in prolonged intubation time and an increased risk of complications. By clarifying the efficiency and safety profiles of each device, this study aims to provide objective evidence to guide the selection of the initial device in routine clinical practice. In particular, this study will examine whether video laryngoscopes reduce intubation time compared with direct laryngoscopes, and whether fiberoptic bronchoscopes reduce complications such as bleeding and postoperative hoarseness. Furthermore, the relationship between device performance and operator experience will be evaluated to inform appropriate training strategies. This study is expected to contribute to the optimization of device selection in nasotracheal intubation and to improve the quality and safety of perioperative airway management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total intubation time (seconds) (start: insertion of the endotracheal tube into the nostril; end: confirmation of the ETCO2 waveform)
Key secondary outcomes
First-attempt intubation success rate
Overall success rate (within a maximum of three attempts)
Number of intubation attempts
Occurrence of hypoxemia (SpO2 < 90%)
Epistaxis (presence of bleeding requiring suction)
Operator experience (years) and number of previous nasotracheal intubations performed
Presence of postoperative sore throat
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
This study is a prospective interventional comparative study using three types of intubation devices: video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes.
Eligible patients will be randomly assigned to one of the three devices using computer-generated allocation. If a video laryngoscope is assigned, intubation will be performed using the video laryngoscope, with up to three attempts permitted. If intubation is unsuccessful after three attempts, subsequent management will be determined at the discretion of the attending anesthesiologist. Perioperative management other than intubation will follow standard clinical practice.
Interventions/Control_2
This study is a prospective interventional comparative study using three types of intubation devices: video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes.
Eligible patients will be randomly assigned to one of the three devices using computer-generated allocation. If a direct laryngoscope is assigned, intubation will be performed using the direct laryngoscope, with up to three attempts permitted. If intubation is unsuccessful after three attempts, subsequent management will be determined at the discretion of the attending anesthesiologist. Perioperative management other than intubation will follow standard clinical practice.
Interventions/Control_3
This study is a prospective interventional comparative study using three types of intubation devices: video laryngoscopes, direct laryngoscopes, and fiberoptic bronchoscopes.
Eligible patients will be randomly assigned to one of the three devices using computer-generated allocation. If a fiberoptic bronchoscope is assigned, intubation will be performed using the fiberoptic bronchoscope, with up to three attempts permitted. If intubation is unsuccessful after three attempts, subsequent management will be determined at the discretion of the attending anesthesiologist. Perioperative management other than intubation will follow standard clinical practice.
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
Adult patients aged 18 years or older
Patients undergoing dental and oral and maxillofacial surgery under general anesthesia
Patients in whom nasotracheal intubation is clinically indicated
Patients who provide written informed consent
Key exclusion criteria
Patients with nasal obstruction, deformity, or asymmetry identified on CT or panoramic radiography
Patients with anticipated difficult intubation
Patients at high risk of bleeding, including those with coagulation disorders or receiving anticoagulant therapy
Patients judged to be unsuitable for safe participation in the study
Target sample size
162
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Tsukamoto |
Organization
Kagoshima University Hospital
Division name
Systemic Management for Dentistry
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL
0992756288
tsukamoto@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Tsukamoto |
Organization
Kagoshima University Hospital
Division name
Systemic Management for Dentistry
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, Japan
TEL
0992756288
Homepage URL
tsukamoto@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Tsukamoto Masanori
Funding Source
Organization
Kagoshima University Hospital
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
Kagoshima University Sakuragaoka Campus Clinical Research Ethics Committee
Address
8-35-1 Sakuragaoka, Kagoshima-shi, Kagoshima, 890-8520, Japan
Tel
0992756624
crmc@m2.kufm.kagoshima-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
| 2026 | Year | 04 | Month | 16 | 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 | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 04 | Month | 16 | Day |
Last modified on
| 2026 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069995
