UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041116
Receipt number R000046241
Scientific Title Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research
Date of disclosure of the study information 2020/10/01
Last modified on 2021/01/14 13:42:38

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Basic information

Public title

Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research

Acronym

Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research

Scientific Title

Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research

Scientific Title:Acronym

Efficacy of nasal high flow therapy for respiratory management in patients after sagittal splitting ramus osteotomy research

Region

Japan


Condition

Condition

after sagittal splitting ramus osteotomy

Classification by specialty

Anesthesiology Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether nasal high flow therapy is more effective than conventional oxygen administration with a simple face mask in patients after sagittal splitting ramus osteotomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Continuous measurements of partial pressure of carbon dioxide and oxygen by arterial blood gas analysis and transcutaneous gas monitor from 0 hours after return to the ward to the time of waking up the next morning

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

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 high flow therapy

Interventions/Control_2

From 0 hours after returning to the ward until waking up the next morning

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing sagittal splitting ramus osteotomy for jaw deformity

Key exclusion criteria

Patients with respiratory diseases
Patients with American Society of Anesthesiologists systemic classification of 3 or higher
Patients who cannot consent to post-operative arterial line implantation and percutaneous monitoring on the ward
Patients with suspected COVID-19 infection

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Yukiko
Middle name
Last name Baba

Organization

Tokyo medical and dental university graduate school of medical and dental sciences

Division name

dental anesthesiology and olofacial pain management

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

0358035549

Email

yukianph@tmd.ac.jp


Public contact

Name of contact person

1st name Yukiko
Middle name
Last name Baba

Organization

Tokyo medical and dental university graduate school of medical and dental sciences

Division name

dental anesthesiology and olofacial pain management

Zip code

113-8549

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL

0358035549

Homepage URL


Email

yukianph@tmd.ac.jp


Sponsor or person

Institute

Tokyo medical and dental university graduate school of medical and dental sciences
dental anesthesiology and olofacial pain management

Institute

Department

Personal name



Funding Source

Organization

Tokyo medical and dental university graduate school of medical and dental sciences

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

Ethical Committee of Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

Tel

0358035404

Email

d-hyoka.adm@tmd.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

2020 Year 10 Month 01 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

2021 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2025 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

2020 Year 07 Month 15 Day

Last modified on

2021 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name