UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006326 |
|---|---|
| Receipt number | R000007501 |
| Scientific Title | Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2012/07/03 22:04:52 |
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Basic information
Public title
Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Acronym
Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Scientific Title
Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Scientific Title:Acronym
Respiratory characteristics during control ventilation and spontaneous breathing trial in patients with mechanical ventilation
Region
| Japan |
Condition
Condition
Patients received mechanical ventilation in ICU
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined tracheal pressure in the expiratory phase and imposed expiratory work of brathing by the endotrachal tube and the ventilator in ICU patients received mechanical ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We hypothesized that imposed patients respiratory load in expiratory phase by an endotrachal tube and a ventilator would be increased in case of increased ventilatory demand.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient received mechanical ventilation more than 48 hr
Key exclusion criteria
Patients with tracheostomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Uchiyama |
Organization
Osaka University Hospital
Division name
Intensive care unit
Zip code
Address
2-15Yamadaoka Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Hospital
Division name
Intensive care unit
Zip code
Address
TEL
81-6-6879-5824
Homepage URL
Sponsor or person
Institute
ICU Osaka Unversity Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | 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
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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Patients receiving mechanical ventilation were studied in an ICU. We measured airway pressure and respiratory flow during assist control mode (A/C) or during SBT which was performed in CPAP + pressure support ventilation mode.
Management information
Registered date
| 2011 | Year | 09 | Month | 11 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007501
