UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034147 |
|---|---|
| Receipt number | R000038920 |
| Scientific Title | Transpulmonary pressure measurement in the intansive care unit; single center observational study |
| Date of disclosure of the study information | 2018/09/14 |
| Last modified on | 2018/09/14 15:07:26 |
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Basic information
Public title
Transpulmonary pressure measurement in the intansive care unit; single center observational study
Acronym
Transpulmonary pressure measurement in the intansive care unit
Scientific Title
Transpulmonary pressure measurement in the intansive care unit; single center observational study
Scientific Title:Acronym
Transpulmonary pressure measurement in the intansive care unit
Region
| Japan |
Condition
Condition
Patients over 20 years old, respiratory management by mechanical ventilator in the intensive care unit
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safty of measurement of pulmonary pressure measurement during acute phase rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changeing the transpulmonary pressure with patients' positioning
Key secondary outcomes
measurement data (mechanical ventilation data), duration of mechanical ventilation, adverse event
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Resieving intensive care in the Unit
2. Resieving mechanical ventilation more than 24 hours
3. 20 years old or more
Key exclusion criteria
1. any neoplasm at esophagous
2. any sign of varix at esophagous
3. veto from physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kota Kamizato |
Organization
University of the Ryukyus
Division name
Department of Anesthesiology
Zip code
Address
207 Uehara Nishihara-cho, Okinawa, Japan
TEL
+81-98-895-3331
kotakami@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kota Kamizato |
Organization
University of the Ryukyus
Division name
Ryukyu University Hospital
Zip code
Address
207 Uehara Nishihara-cho, Okinawa, Japan
TEL
+81-895-3331
Homepage URL
kotakami@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 14 | 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 | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
measurment data chenging of transpulmonary pressure with positioning.
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038920
