UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043290 |
|---|---|
| Receipt number | R000049302 |
| Scientific Title | Research on effect of preceding inspiration method and cough timing on coughing power |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2022/02/11 19:03:47 |
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Basic information
Public title
Effect of preceding inspiration method and cough timing on coughing power
Acronym
Effect of preceding inspiration method and cough timing on coughing power
Scientific Title
Research on effect of preceding inspiration method and cough timing on coughing power
Scientific Title:Acronym
Research on effect of preceding inspiration method and cough timing on coughing power
Region
| Japan |
Condition
Condition
Obstructive ventilatory disturbance, Restrictive ventilatory disturbance
Classification by specialty
| Pneumology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To examine the differences in cough force depending on the inspiration method and cough timing, and to establish an appropriate measurement method for coughing power.
2.To examine the differences in measurement results between normal subjects and patients with respiratory diseases, and to contribute not only to measurement but also to coughing practice and patient guidance in respiratory physiotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak cough flow
Key secondary outcomes
Forced Vital Capacity
Percent predicted Forced Vital Capacity
Forced Expiratory Volume in 1 second
Percent predicted Forced Expiratory Volume in one second
Forced Expiratory Volume in 1 second as percent of FVC
Percent predicted Forced Expiratory Volume in 1 second as percent of FVC
Maximal Voluntary Ventilation
Percent predicted Maximal Voluntary Ventilation
Peak Expiratory Flow
Percent predicted Peak Expiratory Flow
V75-25
Percent predicted V75-25
Peak inspiratory Flow
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Coughing power test
For this measurement, the spirometer will be attached to a mask for expiratory gas analysis. The coughing power(peak cough flow:PCF) is measured under the following four conditions.
Method 1: Cough without an end-inspiratory pause after fast inspiration
Method 2: Cough with an end-inspiratory pause after fast inspiration
Method 3: Cough without an end-inspiratory pause after slow inspiration
Method 4: Cough with an end-inspiratory pause after slow inspiration
For an end-inspiratory pause, the subject watch a timer and coughing after 4 to 6 seconds of respiratory arrest. The measurement position should be sitting, or wheelchair or chair sitting if the sitting position is unstable. The measurement consists of two or three practice sessions, followed by three measurements, and the one with the maximum PCF value is adopted.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subject
1) Healthy subjects over 20 years old
2) Subjects who can give consent in writing for participation in this study
3) Non-smokers or light smokers with a Brinkman index of less than 100
Respiratory disease patients
1) Patients aged over 20 years old
2)Patients who can give consent in writing for participation in this study
3) Patients who are outpatients at Gunma University Hospital
4) Patient with restrictive ventilation disorder or obstructive ventilation disorder
Key exclusion criteria
1)Patients with unexplained blood sputum
2) Patients diagnosed with angina pectoris
3) Patients suffering from unstable cardiovascular disease
4) Patients diagnosed with myocardial infarction or pulmonary embolism
5) Patients with aortic aneurysm
6) Patients immediately after eye surgery (cataract or glaucoma)
7) Patients who have undergone thoracic or abdominal surgery
8) Patients who are unable to give explanation and consent due to cognitive function or psychiatric symptoms
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hisada |
Organization
Gunma University
Division name
Graduate School of Health Sciences / Department of Respiratory Medicine and Allergy
Zip code
371-8514
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8944
hisadat@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hisada |
Organization
Gunma University
Division name
Graduate School of Health Sciences / Department of Respiratory Medicine and Allergy
Zip code
371-8511
Address
3-39-22, Showa-machi, Maebashi, Gunma
TEL
027-220-8944
Homepage URL
hisadat@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15, Showa-machi, Maebashi, Gunma
Tel
027-220-8740
gunmaciru-office@umin.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
群馬大学医学部附属病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 15 | 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
30
Results
Compared to cough with an end-inspiratory pause after slow inspiration (method 4) significantly higher PCF was measured in cough without an end-inspiratory pause after rapid inspiration (method1), and in cough without an end-inspiratory pause after slow inspiration (method 3), in healthy subjects and patients with restrictive ventilation disorder. In addition, PCF was significantly higher in method 1 coughing compared to method 4 coughing in patients with obstructive ventilatory impairment.
Results date posted
| 2022 | Year | 02 | Month | 11 | Day |
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 | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 02 | Month | 09 | Day |
Last modified on
| 2022 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049302
