UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043252 |
|---|---|
| Receipt number | R000049359 |
| Scientific Title | Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position |
| Date of disclosure of the study information | 2021/02/04 |
| Last modified on | 2021/02/04 17:05:55 |
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Basic information
Public title
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Acronym
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Scientific Title
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Scientific Title:Acronym
Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Region
| Japan |
Condition
Condition
Perioperative Complication
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify
whether the lung recruitment during laparoscopic surgery in Trendelenburg
head-down position prevents hypoxemia due to lung collapse.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of hypoxia and Time to onset of hypoxia
Key secondary outcomes
Rate of decrease in SpO2
Ventilator setting at the end of surgery
Compliance rate of lung recruitment
Safety endpoint: Circulatory agonist use
Circulatory agonist use, total fluid infusion, the incidence of complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
lung recruitment.
Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
Interventions/Control_2
Standard ventilatory management.
After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs,if necessary. [initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight(PBW).
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
Patients undergoing low head laparoscopic surgery who are expected to
be laparoscopic for more than 2 hours
Key exclusion criteria
Lateral or supine position
BMI > 35
One-second rate <70%, %VC <80%, obstructive, restrictive, with bra
Cardiovascular disease (NYHA III or higher)
Intracranial hypertensive disease
Emergency surgery
Pregnancy
Patients judged unsuitable by the anesthesiologist in charge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6879-5820
fujino@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Fujino |
Organization
Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
+81-6-6879-5820
Homepage URL
fujino@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Toho University Ohashi Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Osaka University Hospital
Address
2-2 Yamadaoka, Suita city, Osaka, 565-0871 JAPAN
Tel
+81662108296
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）、東邦大学医療センター大橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049359
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
