UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052196 |
|---|---|
| Receipt number | R000059455 |
| Scientific Title | Practical open lung ventilation strategy in the low respiratory compliance cases |
| Date of disclosure of the study information | 2023/09/14 |
| Last modified on | 2023/12/22 23:57:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Practical open lung ventilation strategy in the low respiratory compliance cases
Acronym
Quest for practical open lung ventilation strategy
Scientific Title
Practical open lung ventilation strategy in the low respiratory compliance cases
Scientific Title:Acronym
Quest for practical open lung ventilation strategy
Region
| Japan |
Condition
Condition
Anaesthesia in obese patients undergoing robot-assisted laparoscopic radical prostatectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pressure-controlled inverse ratio ventilation (PC-IRV) with I:E ratio of 3:1-4:1 under PEEP off reduces physiological dead space effectively. However, PC-IRV with I:E ratio of 3:1-4:1 under PEEP off has a potential risk of hyper-inflation.
We hypothesized that PC-IRV with I:E ratio of 1:1-2:1 under PEEP 5 cmH2O would become a practical and safe open lung ventilation strategy in low respiratory compliance situations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physiological dead space during ventilation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Using respiratory ventilation (Engstrom Caredtation, GE Healthcare), interventions start after Trendelenburg position and pneumoperitoneum were established. Using PC-VG mode, the target volume is set to 6 -8 ml/kg of ideal body weight. Respiratory rate is set to 12 bpm.
Control; I:E ratio of 1:2, PEEP of 5 cmH2O for 30 min.
Interventions/Control_2
Conventional PC-IRV; I:E ratio of 4:1, PEEP of 0 cmH2O for 30 min.
Interventions/Control_3
Practical PC-IRV; I:E ratio of 1.5:1, PEEP 5 cmH2O, for 30 min.
Interventions/Control_4
High PEEP strategy; I:E ratio of 1:2, PEEP 10 cmH2O, for 30 min.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
The study included patients with BMI >25 kg/m2 scheduled to undergo robot-assisted laparoscopic radical prostatectomy.
Key exclusion criteria
The exclusion criteria were ASA physical status of 3-5, a history of asthma, pulmonary emphysema, pneumothorax, or lung surgery.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Hirabayashi |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
213-8507
Address
5-1-1 Futako Takatsu-Ku Kawasaki Kanagawa
TEL
+81448443333
goh@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Hirabayashi |
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Division name
Anesthesiology
Zip code
213-8507
Address
5-1-1 Futako Takatsu-Ku Kawasaki Kanagawa
TEL
+81448443333
Homepage URL
goh@med.teikyo-u.ac.jp
Sponsor or person
Institute
Mizonokuchi Hospital, Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mizonokuchi Hospital, Teikyo University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical trial office, Teikyo University School of Medicine
Address
2-11-1 Kaga Itabashi-Ku Tokyo
Tel
03-3964-9358
chiken@med.teikyo-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
| 2023 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059455
