UMIN-CTR Clinical Trial

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