UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047393 |
|---|---|
| Receipt number | R000053424 |
| Scientific Title | Effectiveness of cuff-inflation technique with McGRATH video laryngoscopy for nasotracheal intubation |
| Date of disclosure of the study information | 2022/04/05 |
| Last modified on | 2025/02/23 17:20:27 |
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Basic information
Public title
Effectiveness of cuff-inflation technique with McGRATH video laryngoscopy for nasotracheal intubation
Acronym
Effectiveness of cuff-inflation technique with video laryngoscopy for nasotracheal intubation
Scientific Title
Effectiveness of cuff-inflation technique with McGRATH video laryngoscopy for nasotracheal intubation
Scientific Title:Acronym
Effectiveness of cuff-inflation technique with video larygoscopy for nasotracheal intubation
Region
| Japan |
Condition
Condition
Patients undergoing nasotracheal intubation
Classification by specialty
| Oto-rhino-laryngology | Plastic surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether a method of temporary cuff inflation increases the success rate of nasotracheal intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of the nasotracheal intubation with temporary cuff inflation method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Temporary cuff inflation maneuver for nasotracheal intubation
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
American Society of Anesthesiologist (ASA) physical status 1 or 2
Key exclusion criteria
trismus
neck disorder
severe respiratory disorder
Target sample size
73
Research contact person
Name of lead principal investigator
| 1st name | Noriya |
| Middle name | |
| Last name | Hirose |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan.
TEL
0339728111
hirose.noriya@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriya |
| Middle name | |
| Last name | Hirose |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan.
TEL
0339728111
Homepage URL
hirose.noriya@nihon-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nihon University School of Medicine
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
Hospital Ethics Committee on Human Rights in Clinical Trials and Research of Nihon University Itabashi Hospital
Address
Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan.
Tel
0339728111
komoda.nozomi@nihon-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
| 2022 | Year | 04 | Month | 05 | 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
72
Results
The study was carried out for 72 patients (nasul RAE-tube group; n=36, spiral tube group; n=36 ). The cumulative numbers of successful intubation were 18 (50%) in the first step, 35 (97%) in the second step, and 36 (100%) in the third step in nasul RAE-tube group, and 17 (47%) in the first step and 36 (100%) in the second step in spiral tube group, respectively.
Results date posted
| 2023 | Year | 06 | Month | 10 | Day |
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 | 02 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053424
