UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053153 |
|---|---|
| Receipt number | R000060663 |
| Scientific Title | Study on prevention of redness and pressure sores on the nasal wings in association with nasotracheal intubation |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2024/01/09 13:08:55 |
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Basic information
Public title
Study on prevention of redness and pressure sores on the nasal wings in association with nasotracheal intubation
Acronym
Study on prevention of redness and pressure sores on the nasal wings in association with nasotracheal intubation
Scientific Title
Study on prevention of redness and pressure sores on the nasal wings in association with nasotracheal intubation
Scientific Title:Acronym
Study on prevention of redness and pressure sores on the nasal wings in association with nasotracheal intubation
Region
| Japan |
Condition
Condition
Common oral diseases
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a previous study, we demonstrated that surgical tape, a cushion used to prevent bedsores, is very effective in preventing redness and ulceration during nasotracheal intubation. However, since the tape must be applied directly to the skin, it is used very infrequently and does not cause clinical problems, but there are some limitations, such as skin redness associated with the application of the tape itself and the fact that it cannot be used on patients with sensitive skin.
The 3M Reston Adhesive Foam Pad is a breathable sponge that effectively disperses pressure on the skin. Because the adhesive surface is applied to the surface of medical devices rather than to the skin, we hypothesized that this formulation might be effective in preventing pressure ulcers during nasotracheal intubation.
This study was designed to clarify whether the pressure ulcer prevention method of applying the Reston adhesive foam pad directly to the tracheal tube is as effective as or more effective than surgical tape.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Redness or ulceration of the nasal wing after extubation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After nasotracheal intubation, the Reston Adhesive Foam Pad is applied to the intubation tube.
Interventions/Control_2
After nasotracheal intubation, Surgical Tape is applied to the intubation 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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA PS 1 or 2
Healthy adults
Key exclusion criteria
Patients with narrowed nostrils
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Okuda |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology
Zip code
464-8651
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL
052-759-2111
okudamacbookpro@gmail.com
Public contact
Name of contact person
| 1st name | Aiji |
| Middle name | |
| Last name | Sato |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology
Zip code
464-8651
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, 464-8651, Japan
TEL
052-759-2111
Homepage URL
bokuaiji@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin 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
Aichigakuin University, School of Dentistry, IRB
Address
1-100 Kusumotocho, Chikusa-ku, Nagoya, Aichi, 464-86
Tel
052-751-2561
shigaku@pref.lg.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
愛知学院大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | 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
Management information
Registered date
| 2023 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060663
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