UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060558 |
|---|---|
| Receipt number | R000069274 |
| Scientific Title | Comparison of Perioperative Complications Between Cuffed and Cuffless Tubes in Pediatric Nasotracheal Intubation: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/02/04 |
| Last modified on | 2026/02/03 11:15:11 |
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Basic information
Public title
A Study on the Incidence of Perioperative Complications Associated with the Presence or Absence of a Cuff in Endotracheal Tubes During Pediatric Nasal Intubation
Acronym
Perioperative Complications Associated with Endotracheal Tubes During Pediatric Nasal Intubation
Scientific Title
Comparison of Perioperative Complications Between Cuffed and Cuffless Tubes in Pediatric Nasotracheal Intubation: A Randomized Controlled Trial
Scientific Title:Acronym
Pediatric Nasotracheal Cuff study
Region
| Japan |
Condition
Condition
Dental phobia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Traditionally, cuffless endotracheal tubes were frequently chosen for airway management during general anesthesia in pediatric patients. In recent years, cuffed endotracheal tubes have become more commonly used during orotracheal intubation. This has been shown to reduce the need for tube exchange and lower the reintubation rate. For non-cooperative pediatric patients undergoing general anesthesia, nasopharyngeal intubation is often chosen. However, selecting the appropriate tube size is frequently challenging due to the difference in diameter between the trachea and the nasal cavity. While cuffed tubes reduce reintubation rates, they can also cause damage to the nasal mucosa during passage through the nasal cavity or be obstructed by the cuff itself. Consequently, there is currently no significant difference in the usage rates of the two types of tubes, and the choice is left to the discretion of the anesthesiologist.
This study aimed to determine the optimal endotracheal tube for pediatric nasotracheal intubation by comparing nasotracheal intubation using cuffless tubes versus cuffed tubes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of epistaxis after nasal passage and after extubation
Key secondary outcomes
Ease of nasal passage
Need for tube replacement
Intubation time
Presence of postoperative sore throat or nasal pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Nasal endotracheal intubation with a cuffed endotracheal tube
Interventions/Control_2
Nasal endotracheal intubation without a cuffed endotracheal tube
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
| 3 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Forty children aged 3 to 12 years with no systemic diseases who were non-cooperative for treatment, scheduled for dental treatment under general anesthesia, and for whom informed consent was obtained from their guardians.
Key exclusion criteria
Patients with systemic disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Sago |
Organization
Kyushu Dental University
Division name
Division of Dental Anesthesiology and Pain Management
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
TEL
093-582-1131
r07sagou@fa.ku-dent.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Sago |
Organization
Kyushu Dental University
Division name
Division of Dental Anesthesiology and Pain Management
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
TEL
093-582-1131
Homepage URL
r07sagou@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Dental University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental University Ethics Review Committee
Address
2-6-1 Manazuru, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
Tel
083-582-1131
r07sagou@fa.kyu-dent.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 | 02 | Month | 04 | 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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 01 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069274
