UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049437 |
|---|---|
| Receipt number | R000056288 |
| Scientific Title | Effect of mechanical insufflation-exsufflation on respiratory system compliance and respiratory system resistance in patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation, and factors affecting mechanical insufflation exsufflation-expiratory flows |
| Date of disclosure of the study information | 2022/11/06 |
| Last modified on | 2023/05/08 18:04:14 |
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Basic information
Public title
Effect of mechanical insufflation-exsufflation on respiratory system compliance and respiratory system resistance in patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation, and factors affecting mechanical insufflation exsufflation-expiratory flows
Acronym
Effect of mechanical insufflation-exsufflation on respiratory system compliance and respiratory system resistance in patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation, and factors affecting mechanical insufflation exsufflation-expiratory flows
Scientific Title
Effect of mechanical insufflation-exsufflation on respiratory system compliance and respiratory system resistance in patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation, and factors affecting mechanical insufflation exsufflation-expiratory flows
Scientific Title:Acronym
Effect of mechanical insufflation-exsufflation on respiratory system compliance and respiratory system resistance in patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation, and factors affecting mechanical insufflation exsufflation-expiratory flows
Region
| Japan |
Condition
Condition
Neuromuscular disease
Classification by specialty
| Neurology | Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of different mechanical insufflation-exsufflation settings on respiratory system compliance and respiratory system resistance in patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation. Furthermore, we examine the factors that affect mechanical insufflation exsufflation-expiratory flows.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory system compliance, respiratory system resistance and mechanical insufflation exsufflation-expiratory flows.
Key secondary outcomes
Plateau pressure, peak inspiratory pressure, mean airway pressure, SpO2, EtCO2, pulse, age, male, height, weight, BMI, disease duration, duration of TMV, biochemical examination of blood, vital capacity, finding from study of images.
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
| Device,equipment | Maneuver |
Interventions/Control_1
Mechanical insufflation exsufflation (Set pressures 20, 30, and 40cmH2O)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with neuromuscular disease using tracheostomy and invasive mechanical ventilation
Key exclusion criteria
1)Patients with a history of pneumothorax
2)Patients with progressive lung disease
3)Patients with unstable hemodynamics due to heart failure
4)Patients who have difficulty in measuring respiratory system compliance and respiratory system resistance using a ventilator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | M. |
| Last name | Sato |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Department of Rehabilitation
Zip code
740-8510
Address
1-1-1 Atago, Iwakuni City, Yamaguchi, 740-8510, Japan
TEL
0827-34-1000
y.sato1214@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | M. |
| Last name | Sato |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Department of Rehabilitation
Zip code
740-8510
Address
1-1-1 Atago, Iwakuni City, Yamaguchi, 740-8510, Japan
TEL
0827-34-1000
Homepage URL
y.sato1214@gmail.com
Sponsor or person
Institute
National Hospital Organization Iwakuni Clinical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Iwakuni Clinical Center
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
National Hospital Organization Hiroshima Nishi Medical Center Ethics Committee
Address
4-1-1 Kuba, Ootake City, Hiroshima, 739-0696, Japan
Tel
0827-57-7151
y.sato1214@gmail.com
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
| 2022 | Year | 11 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 11 | Month | 05 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056288
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