UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017745 |
|---|---|
| Receipt number | R000018704 |
| Scientific Title | Detection of best positive end expiratory pressure in post-cardiovascular surgery patients |
| Date of disclosure of the study information | 2015/05/31 |
| Last modified on | 2022/06/28 23:14:06 |
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Basic information
Public title
Detection of best positive end expiratory pressure in post-cardiovascular surgery patients
Acronym
Best PEEP in post-cardiac surgery patients
Scientific Title
Detection of best positive end expiratory pressure in post-cardiovascular surgery patients
Scientific Title:Acronym
Best PEEP in post-cardiac surgery patients
Region
| Japan |
Condition
Condition
patients after cardiovascular surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect best positive end expiratory pressure derived from electrical impedance tomography (EIT) data in patients after cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PaO2,Comliance,EIT
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
PEEP titration were performed using guidance with EIT.
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
cardiac surgery patients requiring cardiopulmonary bypass
Key exclusion criteria
pregnancy,lung bullae
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Bito |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8575
kiyokobitoxxx@s5.dion.ne.jp
Public contact
Name of contact person
| 1st name | Kiyoko |
| Middle name | |
| Last name | Bito |
Organization
Showa University School of Medicine
Division name
Department of Anesthesiology
Zip code
1428666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8575
Homepage URL
kiyokobitoxxx@s5.dion.ne.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Showa university
Address
1-5-8, Hatanodai, Shinagawa, Tokyo
Tel
0337848575
kiyokobitoxxx@s5.dion.ne.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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2077-0383/11/11/3022/pdf
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/11/11/3022/pdf
Number of participants that the trial has enrolled
40
Results
Compared with the values before the PEEP trial, ventilation distributions of the dependent region increased at 5 min after the PEEP online setting and were maintained at 1 h thereafter. Oxygenation also showed sustained improvement.
Results date posted
| 2022 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included patients who had undergone elective cardiac surgery using cardiopulmonary bypass and who were admitted to intensive care units (ICUs) between June 2015 and December 2017.
Participant flow
All patients provided written informed consent before surgery.
Adverse events
Forty patients were initially enrolled in this study. However, PEEP decreased in five patients because of hemodynamic instability; thus, their data were excluded.
Outcome measures
The primary outcome of our study was the effect of PEEP online on ventilation distribution in the dependent region assessed by Electrical impedance tomography. Secondary outcomes were the ratio of arterial oxygen partial pressure to inspiratory oxygen fraction and respiratory compliance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018704
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/06/05 | jcm-11-03022.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/06/05 | jcm-11-03022.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/06/05 | jcm-11-03022.pdf |
