UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045124 |
|---|---|
| Receipt number | R000051548 |
| Scientific Title | Evaluation of ventilation distribution with Electrical Impedance Tomography in mechanically ventilated patients after surgery |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2024/07/18 20:28:01 |
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Basic information
Public title
Evaluation of ventilation distribution in mechanically ventilated patients after surgery
Acronym
Evaluation of ventilation distribution in mechanically ventilated patients after surgery
Scientific Title
Evaluation of ventilation distribution with Electrical Impedance Tomography in mechanically ventilated patients after surgery
Scientific Title:Acronym
EIT after surgery
Region
| Japan |
Condition
Condition
patients after surgery
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of ventilation distribution
Basic objectives2
Others
Basic objectives -Others
relationship between intrapulmonary ventilation distribution and postoperative pulmonary complication score
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship between intrapulmonary ventilation ditribution and postoperative respiratory complication score at entering the ICU and before extubation or forty eight hours after surgery
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients over eighteen years old after surgery
patients undergoing mechanical ventilation after surgery
postoperative pulmonary complication high risk patients
Key exclusion criteria
patients undergoing mechanical ventilation before surgery
patients with an implantable pacemaker
patients with ventricular assist device
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yoshida |
| Middle name | |
| Last name | Takeshi |
Organization
Osaka university Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
Osaka suita city yamadaoka 2-15
TEL
06-6879-3133
takeshiyoshida@hp-icu.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Iwata |
| Middle name | |
| Last name | Hirofumi |
Organization
Osaka university Graduate School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
Osaka suita city yamadaoka 2-15
TEL
06-6879-3133
Homepage URL
hi38655072@yahoo.co.jp
Sponsor or person
Institute
Osaka university Graduate School of Medicine,Department of Anesthesiology and Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Osaka University Hospital
Address
Osaka suita city yamadaoka 2-2
Tel
06-6210-8290
jim-chiken@hp-crc.med.osaka-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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
130
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
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051548
