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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018729
Receipt No. 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

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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
Email 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
Email myoko@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

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
Email 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
URL(English) https://upload.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


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