UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029677 |
|---|---|
| Receipt number | R000033911 |
| Scientific Title | Effect of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy. |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2024/04/29 09:41:25 |
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Basic information
Public title
Effect of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Acronym
Effect of alveolar recruitment maneuvers and positive end-expiratory pressure for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Scientific Title
Effect of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Scientific Title:Acronym
Effect of alveolar recruitment maneuvers and positive end-expiratory pressure for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Region
| Japan |
Condition
Condition
the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the Effecacy of alveolar recruitment maneuvers and positive end-expiratory pressure on postoperative atelectasis during general anesthesia for the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative atelectasis
Key secondary outcomes
intraoperative and Postoperative oxygenation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
recruitment manuever
Interventions/Control_2
positive end-expiratory pressure
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective, the laparoscopic nephrectomy and the robotically-assisted laparoscopic prostatectomy under general anesthesia
Key exclusion criteria
Abnormal pulmonary function
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Division name
Department of Anesthesiology & Reanimatology
Zip code
91011
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL
0776618391
ymatsuki@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Division name
Department of Anesthesiology & Reanimatology
Zip code
9101193
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL
0776-61-8391
Homepage URL
ymatsuki@u-fukui.ac.jp
Sponsor or person
Institute
Department of Anesthesiology & Reanimatology, University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
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
University of Fukui, Faculty of Medicine Sciences, Fukui, Japan
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
Tel
0776618529
rinsho-rinri@ml.u-fukui.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
| 2017 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.apicareonline.com/index.php/APIC/article/view/2407
Publication of results
Unpublished
Result
URL related to results and publications
https://www.apicareonline.com/index.php/APIC/article/view/2407
Number of participants that the trial has enrolled
40
Results
The time depended difference in Crs was significantly higher in the RM group than in the non-RM group. Postoperative atelectasis occurred in one patient in the PEEP group, whose Crs was 34 cmH2O/mL at the time of intubation. In the subgroup with initial low Crs (< 60 cmH2O/mL), the time-dependent difference in Crs was significantly higher in the RM group than the PEEP group.
Results date posted
| 2024 | Year | 04 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between 19 patients in the RM group and 17 patients in the PEEP group, no significant differences in patients'demography.
Participant flow
The patients were randomly allocated to either PEEP (5-8 cmH2O plus alveolar RM of 30 cmH2O for 20 sec (RM group) or PEEP (5-8 cmH2O) only (PEEP group). In the RM group, the RM was performed at predetermined several time points and every 30 min during pneumoperitoneum. All patients received volume-guaranteed pressure-controlled ventilation with a tidal volume of 6-8 ml/kg(ideal body weight).
Adverse events
There were no adverse events.
Outcome measures
Time-dependent differences between the groups
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033911
