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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030787
Receipt No. 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 2019/09/12

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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
Email 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
Email nk600113@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of medicine
Institute
Department

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
Email 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 Open public recruiting
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
2020 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
2018 Year 01 Month 12 Day
Last modified on
2019 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035153

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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