UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045524
Receipt number R000051976
Scientific Title A study on prevention of redness and pressure ulcer associated with nasal Intubation using surgical tape
Date of disclosure of the study information 2021/09/21
Last modified on 2022/09/22 10:58:29

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Basic information

Public title

A study on prevention of redness and pressure ulcer associated with nasal Intubation using surgical tape

Acronym

A study on prevention of redness and pressure ulcer associated with nasal Intubation using surgical tape

Scientific Title

A study on prevention of redness and pressure ulcer associated with nasal Intubation using surgical tape

Scientific Title:Acronym

A study on prevention of redness and pressure ulcer associated with nasal Intubation using surgical tape

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study investigates whether surgical tape can be an alternative to hydrocolloid for the prevention of redness and ulcers associated with nasal intubation.

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Surgical tape is applied to the nasal wing after nasal intubation

Interventions/Control_2

Surgical tape is not applied to the nasal wing after nasal intubation

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

100


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

Email

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


Email

bokauiji@dpc.agu.ac.jp


Sponsor or person

Institute

Aichigakuin University, School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Aichigakuin University, School of Dentistry

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

Email

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

2021 Year 09 Month 21 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

Completed

Date of protocol fixation

2021 Year 09 Month 03 Day

Date of IRB

2021 Year 09 Month 03 Day

Anticipated trial start date

2021 Year 09 Month 27 Day

Last follow-up date

2022 Year 12 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

2021 Year 09 Month 21 Day

Last modified on

2022 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name