UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055397 |
|---|---|
| Receipt number | R000063295 |
| Scientific Title | Titration of optimal PEEP using EIT during postoperative mechanical ventilation for patients undergoing minimally invasive cardiac surgery requiring intraoperative one lung ventilation. |
| Date of disclosure of the study information | 2024/09/02 |
| Last modified on | 2024/09/10 15:49:46 |
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Basic information
Public title
Titration of optimal PEEP using EIT during postoperative mechanical ventilation for patients undergoing minimally invasive cardiac surgery requiring intraoperative one lung ventilation.
Acronym
Titration of optimal PEEP using EIT during postoperative mechanical ventilation for patients undergoing MICS.
Scientific Title
Titration of optimal PEEP using EIT during postoperative mechanical ventilation for patients undergoing minimally invasive cardiac surgery requiring intraoperative one lung ventilation.
Scientific Title:Acronym
Titration of optimal PEEP using EIT during postoperative mechanical ventilation for patients undergoing MICS.
Region
| Japan |
Condition
Condition
Patients after minimally invasive cardiac surgery requiring intraoperative one lung ventilation.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In post-operative patients undergoing thoracic surgery, including cardiac surgery, patients with lung injuries have been reported to have longer ICU lengths of stay and increased in-hospital mortality. Previous observational studies have shown that in post-cardiac surgery patients who already discharged from ICU, more than 40% of re-admissions to the indexed ICU were due to respiratory complications, and above all, 23% of cases were post-operative respiratory failure. Risk factors for the development of ARDS after cardiac surgery include emergency surgery, simultaneous coronary and valve surgery, and administration of more than three units of red blood cell transfusion, but none have been established, nor methods to prevent the development of ARDS after surgery.
How to set optimal PEEP in ventilatory management after cardiac surgery has not yet decided. Until now, searching the best oxygenation or the highest lung compliance, and monitoring pressure-volume curve (PV curve) on the ventilator or esophageal pressure have been tried, mainly in patients with ARDS. However, these methods were unable to assess the heterogeneity of the ventilated lungs.
It has been reported that EIT can be used to set optimal PEEP for ventilatory management of patients with ARDS. Similarly, studies have been reported on setting optimal PEEP using EIT in post-operative patients undergoing cardiac surgery, but the included patients were post-operative patients with a median sternotomy only, and no studies have explored the appropriate PEEP levels for ventilatory management in patients after MICS requiring intraoperative one-lung ventilation.
In this study, patients who receive ventilatory management in the ICU after MICS requiring intraoperative one-lung ventilation will be evaluated using EIT to assess ventilation inhomogeneity during mechanical ventilation and to search for the optimal PEEP for each individual that optimizes ventilation distribution and lung compliance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PEEP level that maximize the lung compliance in the operation side.
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
When the eligible patient is admitted to the ICU, an EIT is applied. After measuring the ventilation distribution at the time of admission, alveolar recruitment is performed and the PEEP is set according to the ventilation distribution obtained with the EIT and other indicators.
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
1) Patients admitted to the ICU after MICS requiring intraoperative one-lung ventilation and ventilatory management.
2) Patients who have given their consent to participate in the study.
Key exclusion criteria
1) Patients under 18 years of age.
2) Patients who underwent emergency operation.
3) Patients with circulatory instability.
4) Patients with ECMO or/and P-VAD.
5) Patients with active cardiac pacemaker.
6) Patients with severe thoracic deformity.
7) Patients with pneumothorax.
8) Patients with a history of severe chronic obstructive pulmonary disease.
9) Patients who did not consent to participate in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Uchihkura |
Organization
Yokosuka general hospital Uwamachi
Division name
Department of intensive care
Zip code
2388567
Address
2-36 Uwamachi, Yokosuka, Kanagawa 238-8567, Japan.
TEL
+81-46-823-2630
toshio.uchikura@nifty.com
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Uchikura |
Organization
Yokosuka general hospital Uwamachi
Division name
Department of intensive care
Zip code
2388567
Address
2-36 Uwamachi, Yokosuka, Kanagawa 238-8567, Japan.
TEL
+81-46-823-2630
Homepage URL
toshio.uchikura@nifty.com
Sponsor or person
Institute
Yokosuka general hospital Uwamachi
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
Ethical review board Yokosuka general hospital Uwamachi
Address
2-36 Uwamachi, Yokosuka, Kanagawa 238-8567, Japan.
Tel
+81-46-823-2630
chihoso@jadecom.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
| 2024 | Year | 09 | Month | 02 | 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
| 2024 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063295
