UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023173 |
|---|---|
| Receipt number | R000026709 |
| Scientific Title | Comparison of AutoFlow and conventional volume-controlled ventilation using LMA ProSeal during gynecological laparoscopic surgery |
| Date of disclosure of the study information | 2016/07/14 |
| Last modified on | 2021/07/17 09:45:54 |
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Basic information
Public title
Comparison of AutoFlow and conventional volume-controlled ventilation using LMA ProSeal during gynecological laparoscopic surgery
Acronym
Evaluation of AutoFlow ventilation mode using LMA ProSeal during gynecological laparoscopy
Scientific Title
Comparison of AutoFlow and conventional volume-controlled ventilation using LMA ProSeal during gynecological laparoscopic surgery
Scientific Title:Acronym
Evaluation of AutoFlow ventilation mode using LMA ProSeal during gynecological laparoscopy
Region
| Japan |
Condition
Condition
Patients undergo gynecological laparoscopic surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the application of AutoFlow volume-controlled ventilation mode for gynecological laparoscopic surgery using LMA Proseal
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak airway pressure during pneumoperitoneum and trendelenburg position
Key secondary outcomes
Leak from LMA ProSeal during pneumoperitoneum and trendelenburg position
Peak airway pressure before pneumoperitoneum
Peak airway pressure shortly after initiation of pneumoperitoneum
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional volume-controlled ventilation
Interventions/Control_2
Volume-controlled ventilation using AutoFlow mode
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
Female
Key inclusion criteria
Patients undergo gynecological laparoscopic surgery
Key exclusion criteria
Patients considered inadequate for intraoperative airway management using LMA ProSeal
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
745-8522
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
nakanishi.anest@gmail.com
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Department of Anesthesiology
Zip code
745-8522
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
Homepage URL
nakanishi.anest@gmail.com
Sponsor or person
Institute
JCHO Tokuyama Central Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
JCHO Tokuyama Central Hospital
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
JCHO Tokuyama Central Hospital IRB
Address
1-1 Kohdacho, Shunan city, Yamaguchi, Japan
Tel
0834-28-4411
chiken2@tokuchuhp.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
| 2016 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01406-6
Publication of results
Published
Result
URL related to results and publications
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01406-6
Number of participants that the trial has enrolled
80
Results
Data from 40 patients in the AutoFlow group and 39 in the VCV group were used for analysis. PAWP at pneumoperitoneum pressure and in the Trendelenburg position was significantly lower in the AutoFlow group than in the VCV group [median (interquartile range), 16 (15-18) cmH2O vs. 18 (17-19) cmH2O; P < 0.001]. Airway leak occurred in four patients in the AutoFlow group and in two patients in the VCV group; however, this incidence was not significantly different (P = 0.68).
Results date posted
| 2021 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 28 | Day |
Baseline Characteristics
We screened and recruited 80 adult women undergoing elective laparoscopic gynecological surgery, aged 20-80 years, and with American Society of Anesthesiologists physical status 1 or 2.
Participant flow
Patients who were thought to be unsuitable for management with pLMA, such as those with morbid obesity (body mass index > 35 kg/m2), who have not fasted, or with gastroesophageal reflux disease, were excluded from the study.
Adverse events
None.
Outcome measures
The primary outcome was PAWP during pneumoperitoneum and in the Trendelenburg position, whereas the secondary outcomes included PAWP at other timepoints and airway leak development.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 14 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026709
