UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024975
Receipt number R000028739
Scientific Title Effectiveness of respiratory rate monitoring using non-invasive methods
Date of disclosure of the study information 2016/11/24
Last modified on 2023/07/05 12:10:19

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Basic information

Public title

Effectiveness of respiratory rate monitoring using non-invasive methods

Acronym

Effectiveness of respiratory rate monitoring using non-invasive methods

Scientific Title

Effectiveness of respiratory rate monitoring using non-invasive methods

Scientific Title:Acronym

Effectiveness of respiratory rate monitoring using non-invasive methods

Region

Japan


Condition

Condition

patients who undergo surgeries at Gifu university hospital

Classification by specialty

Surgery in general Gastrointestinal surgery Vascular surgery
Obstetrics and Gynecology Dermatology Orthopedics
Urology Cardiovascular surgery Plastic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We assess respiration rate using clinical respiratory rate monitoring (capnometry and plethysmography) and compare with auscultation of throat breathing.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

respiratory rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

a oxygen mask with capnometry

Interventions/Control_2

a nasal oxygen cannula with capnometry

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

ASA physical status 1-2
20 years old or older
agreed to participate in the study and signed informed consent form

Key exclusion criteria

Patients with severe cerebra-vascular disease,coronary heart disease or respiratory failure

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yuko
Middle name
Last name Yamada

Organization

Gifu University Graduate School of Medicine

Division name

Anesthesiology and Pain Medicine

Zip code

5011194

Address

1-1 Yanagido, Gifu City, Gifu

TEL

058-230-6404

Email

y-comet@wg7.so-net.ne.jp


Public contact

Name of contact person

1st name Yuko
Middle name
Last name Yamada

Organization

Gifu University Graduate School of Medicine

Division name

Anesthesiology and Pain Medicine

Zip code

5011194

Address

1-1 Yanagido, Gifu City, Gifu

TEL

058-230-6404

Homepage URL


Email

y-comet@wg7.so-net.ne.jp


Sponsor or person

Institute

Gifu University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gifu University Graduate School of Medicine

Address

1-1, Yanagido, Gifu-shi, Gifu

Tel

0582306059

Email

rinri@gifu-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

2016 Year 11 Month 24 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

2016 Year 11 Month 17 Day

Date of IRB

2016 Year 07 Month 19 Day

Anticipated trial start date

2016 Year 11 Month 24 Day

Last follow-up date

2020 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 24 Day

Last modified on

2023 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028739


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name