UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018729 |
|---|---|
| Receipt number | R000021663 |
| Scientific Title | Evaluation of function of respiratory muscles using a fine wire electrodes under hypoxia, hypercapnia, posture changing, drugs and ventilator. |
| Date of disclosure of the study information | 2015/08/19 |
| Last modified on | 2020/03/11 08:36:41 |
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Basic information
Public title
Evaluation of function of respiratory muscles using a fine wire electrodes under hypoxia, hypercapnia, posture changing, drugs and ventilator.
Acronym
Evaluation of function of respiratory muscles using a fine wire electrodes.
Scientific Title
Evaluation of function of respiratory muscles using a fine wire electrodes under hypoxia, hypercapnia, posture changing, drugs and ventilator.
Scientific Title:Acronym
Evaluation of function of respiratory muscles using a fine wire electrodes.
Region
| Japan |
Condition
Condition
COPD, interstitial pneumonia, neuromuscular disease
Classification by specialty
| Pneumology | Neurology | Clinical immunology |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to better understanding of the action of respiratory muscles, we measure the EMG activity of respiratory muscles and other ventilatory parameters under hypoxia, hypercapnia, ventilator and respiratory medicine in humans.
Basic objectives2
Others
Basic objectives -Others
To clarify the respiratory muscle activities and coordination of those muscles under hypoxia, hypercapnia, ventilator and respiratory medicine in humans.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
EMG activity of respiratory muscles (i.e. parasternal intercostal, external intercostal, transversus abdominis muscles and so on) obtained by fine wire electrodes.
Key secondary outcomes
Ventilatory parameters (i.e. inspiratory time (TI), expiratory time (TE), total time per breath (TT), frequency of respiration (f), tidal volume (VT) and minute ventilation (VI)), end-tidal CO2 (ETCO2), oxygen saturation values obtained from pulse oximetry (SpO2), and heart rate.
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
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Pair of fine wire electrodes will be inserted, approximately 10 mm apart, into respiratory muscles (ie. parasternal intercostal muscle, transversus abdominis muscle, and so on) guided by high resolution ultrasound echo graph.
Hypoxia: Subjects rebreathed room air from a 6 L bag until the observed SpO2 was approximately 60% or until the subjects exhibited signs of dyspnea.
Hypercapnia: Subjects rebreathed approximately 7% CO2 balanced O2 gas from a 6 L bag until the observed ETCO2 was approximately 10% or until the subjects exhibited signs of dyspnea.
non invasive positive pressure ventilation (NPPV): Subjects breathed via nose with nasal mask that connected to the NPPV. IPAP will be set between 4 to 20 cmH2O.
Aminophylline: A loading dose of aminophylline 9 mg/kg will be administrated in the first hour, followed by a maintenance dose of 0.75 mg/kg/h. The maintenance dose used is equivalent to a standard clinical therapeutic dosage. Venous blood was sampled and serum theophylline concentrations were measured at 0, 60, 90, and 120 min after the initiation of aminophylline administration.
Short acting beta 2 antagonists: Subjects administrated 20 mcg/min of Salbutamol intravenously and we measured some parameters after 2 hours.
Long acting beta 2 antagonists: Subjects inhaled 100 mcg (4 MDI puff) of Salmeterol and we measured some parameters after 2 hours.
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
Key inclusion criteria
healthy adult male subject.
Key exclusion criteria
Subjects who have history of pulmonary or cardiovascular or neuromuscular disorders were excluded.
Subjects who have pointed out some abnormality by pre-study evaluation, including pulmonary function tests, electrocardiography and echocardiography.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yokoba |
Organization
School of Allied Health Sciences, Kitasato University/ Kitasato University Hospital
Division name
Medical Laboratory Sciences/ Pulmonary Medicine
Zip code
194-0001
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
myoko@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Yokoba |
Organization
School of Allied Health Sciences, Kitasato University/ Kitasato University Hospital
Division name
Medical Laboratory Sciences/ Pulmonary Medicine
Zip code
194-0001
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
myoko@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization
Address
Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
042-778-7756
rinri@med.kitasato-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
| 2015 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/24721495
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
Main results already published
Date of protocol fixation
| 2012 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021663
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/09/04 | 研究実施計画_B0204延長v2.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
