UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030787 |
|---|---|
| Receipt number | R000035153 |
| Scientific Title | Assessment of individualized positive end-expiratory pressure on respiratory mechanics and ventilation distribution in morbidly obese patients during laparoscopic surgery |
| Date of disclosure of the study information | 2018/01/12 |
| Last modified on | 2023/04/25 20:06:28 |
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Basic information
Public title
Assessment of individualized positive end-expiratory pressure on respiratory mechanics and ventilation distribution in morbidly obese patients during laparoscopic surgery
Acronym
Effect of PEEP during laparoscopic surgery in obese patients
Scientific Title
Assessment of individualized positive end-expiratory pressure on respiratory mechanics and ventilation distribution in morbidly obese patients during laparoscopic surgery
Scientific Title:Acronym
Effect of PEEP during laparoscopic surgery in obese patients
Region
| Japan |
Condition
Condition
obese
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of individualized positive end-expiratory pressure on respiratory mechanics and ventilation distribution in morbidly obese patients during laparoscopic surgery
Basic objectives2
Others
Basic objectives -Others
Select individualized PEEP and assess change of respiratory mechanics during operation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Assess change of ventilation distribution in dorsal part of lung during individualized PEEP
Key secondary outcomes
Select individualized PEEP and assess change of trans pulmonary pressure during head down and pneumoperitonium.
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
Measure each parameter during spontaneous breathing in Spine position.(T1)
Measure each parameter after intubation under PEEP10 cmH2O during general anesthesia.(T2)
First RM followed by a decremental PEEP titration.
PEEP is set to 25 cmH2O and decrease stepwisely by 2 cmH2O for every 3 min.
Calculate driving pressure at each PEEP, chose individual PEEP.
After second RM, set individual PEEP and 5min later measure each parameter. (T3)
The individualized PEEP is maintained throughout the surgery.Measure each parameter,30 min after initiation of pneumoperitonium (T4),10 min after deflation (T5)and after extubation (T6)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Morbidly obese patients with a BMI > 35 kg / m2 undergoing laparoscopic surgery
Informed consent
ASA-PS:1-2
Key exclusion criteria
Pulmonary comorbidities
COPD grade < 3, or FEV1s < 1000 ml
Heart failure
cardiac index < 1.8 L/m2, NYHA >2
Poorly controlled hypertension
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Katayama |
Organization
Shimane University Faculty of medicine
Division name
Department of Anesthesiology
Zip code
6938501
Address
89-1 Enyachou Izumo Shimane
TEL
0853-20-2295
nk600113@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Katayama |
Organization
Shimane University Faculty of medicine
Division name
Department of Anesthesiology
Zip code
6938501
Address
89-1 Enyachou Izumo Shimane
TEL
0853-20-2295
Homepage URL
nk600113@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty 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
Shimane University Faculty of medicine
Address
89-1 Enyachou Izumo Shimane
Tel
0853-20-2295
nk600113@med.shimane-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
| 2018 | Year | 01 | Month | 12 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035153
