UMIN-CTR Clinical Trial

Public title

Research on differences in respiratory frequency according to measurement time (10-second, 15-second, and 60-second methods)

Acronym

Comparative Tests on Respiratory Rate Measurement Methods

Scientific Title

Comparative study of differences in respiratory frequency according to measurement time (10-second, 15-second, and 60-second methods)

Scientific Title:Acronym

A study of respiratory return measurement

Region

Japan

Condition

The purpose of this study is not to target a specific disease, but to examine differences in measurement results due to differences in respiratory frequency measurement methods. Since the subjects of the study are nurses and the measurements are performed using videos of simulated patients rather than actual patients, the study is not limited to a specific disease.

Classification by specialty

Nursing	Not applicable	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to determine the differences in respiratory frequency measured by different measurement times (10-second, 15-second, and 60-second methods). In particular, we will compare the degree of error of each measurement method in three different respiratory states: slow breathing, normal breathing, and tachypnea. The results of this study are expected to contribute to the selection of an efficient and accurate respiratory frequency measurement method in clinical practice, thereby reducing the burden on healthcare professionals and contributing to the early detection of deteriorating patient conditions.

Basic objectives2

Others

Basic objectives -Others

We will compare the accuracy and practicality of different measurement times (10-second method, 15-second method, and 60-second method) and evaluate the effects of measurement error, especially during abnormal respiration, and the characteristics of the measurer on the results. Furthermore, we will examine the possibility that short-time measurement contributes to reducing the burden on nurses and improving the measurement rate, and aim to establish an optimal respiratory frequency measurement method.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The purpose of this study is to determine the differences in the results of respiratory frequency measurements by different measurement times (10-second, 15-second, and 60-second methods). To this end, we first calculate the mean value and standard deviation of the respiratory frequency for each measurement method, and evaluate the general trend shown by each method. Next, we will analyze the extent to which the 10-second and 15-second methods produce measurement errors when the 60-second method is used as the standard, and clarify any tendency toward overestimation or underestimation. Furthermore, we will examine the effects of different respiratory states and compare the degree of error of each measurement method in different respiratory patterns, such as slow breathing, normal breathing, and tachypnea. Finally, whether statistically significant differences exist between these measurement methods will be evaluated using two-way analysis of variance to determine the magnitude of the impact of differences in measurement time on measurement results.

Key secondary outcomes

The goal is to clarify not only differences in the accuracy of respiratory frequency measurement, but also practical influences in clinical practice, such as measurer proficiency, environment, measurement sequence, and reproducibility.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Other

Interventions/Control_1

The subject is to watch a breathing video of a simulated patient and measure the respiratory frequency using three different methods: 10-second, 15-second, and 60-second methods.
Measurements are taken for three groups: slow breathing, intra-standard breathing, and tachypnea, and the order is randomly assigned. After the measurements, the subjects will answer a questionnaire, and the data will be managed in such a way that individuals cannot be identified. The intervention involves a certain time commitment for the subject.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects shall be nurses who perform respiratory frequency measurements and must be licensed nurses as a selection criterion. Persons with or without clinical experience who understand the purpose of the study and agree to participate will be included.

Key exclusion criteria

Persons who are unable to fully understand the research procedures or who wish to withdraw their consent will also be considered for exclusion.

Target sample size

57

Name of lead principal investigator

1st name	Hikaru
Middle name
Last name	Hashikura

Organization

Tokyo University of Health Sciences

Division name

Tokyo University of Health Sciences Graduate School of Nursing Advanced Practical Nursing Course

Zip code

152-8558

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo

TEL

03-5779-5071

Email

kg024020@thcu.ac.jp

Name of contact person

1st name	Hikaru
Middle name
Last name	Hashikura

Organization

Tokyo University of Health Sciences

Division name

Tokyo University of Health Sciences Graduate School of Nursing Advanced Practical Nursing Course

Zip code

152-8568

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo

TEL

0357795031

Homepage URL

Email

kg024020@thcu.ac.jp

Institute

Tokyo University of Health Sciences

Institute

Department

Personal name

Organization

Tokyo University of Health Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo University of Health Sciences Ethics Committee on Human Research

Address

2-5-1 Higashigaoka, Meguro-ku, Tokyo

Tel

0357795031

Email

kg024020@thcu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

02

Month

18

Day

Date of IRB

Anticipated trial start date

2025

Year

03

Month

15

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 related information

The study is in the pre-study phase; recruitment and enrollment of participants has not yet begun. Research permission from the president of the university is required to conduct the study, and the ethical review and necessary procedures are currently in progress. Therefore, the progress status of this study is "not started," and enrollment of subjects and data collection will begin as soon as research permission is obtained.

Registered date

2025

Year

03

Month

03

Day

Last modified on

2025

Year

03

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065349