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

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 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

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

Value
https://center6.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