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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023173
Receipt No. 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

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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
Email 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
Email nakanishi.anest@gmail.com

Sponsor
Institute JCHO Tokuyama Central Hospital, Department of Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026709

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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