UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034988
Receipt number R000039901
Scientific Title Comparison of two ventilation setting during mechanical mask ventilation
Date of disclosure of the study information 2019/01/01
Last modified on 2024/01/26 10:22:36

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Basic information

Public title

Comparison of two ventilation setting during mechanical mask ventilation

Acronym

Comparison of two ventilation setting during mechanical mask ventilation

Scientific Title

Comparison of two ventilation setting during mechanical mask ventilation

Scientific Title:Acronym

Comparison of two ventilation setting during mechanical mask ventilation

Region

Japan


Condition

Condition

general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare two ventilation setting (pressure control ventilation and pressure control ventilation volume guarantee) during mechanical mask ventilation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

frequency of inflow of air into stomach during mechanical mask ventilation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

to use pressure control ventilation - volume guarantee during mechanical mask ventilation

Interventions/Control_2

To use pressure control ventilation during mechanical mask ventilation

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

86 years-old >

Gender

Male and Female

Key inclusion criteria

patients who are planned a operation which needs general anesthesia at Tokushima University

Key exclusion criteria

Patients who doesn't agree to test

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Katsuya
Middle name
Last name Tanaka

Organization

Tokushima University

Division name

Department of Anesthesiology

Zip code

7708503

Address

Kuramoto Cho, Tokushima City, Tokushima Prefecture

TEL

0886337181

Email

kawanishi.riyosuke@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Kawanishi

Organization

Tokushima University

Division name

Department of Anesthesiology

Zip code

7708503

Address

Kuramoto Cho, Tokushima City, Tokushima Prefecture

TEL

0886337181

Homepage URL


Email

kawanishi.riyosuke@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Review Board of Tokushima University

Address

50-1 2 cho-me, Kuramoto-cho, tokushima-shi, Tokusima-ken, Japan

Tel

0886337958

Email

brinshoshienk@tokushima-u.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

2019 Year 01 Month 01 Day


Related information

URL releasing protocol

https://tocms.ait231.tokushima-u.ac.jp/tocms/detail.php?id=8481&type=kk

Publication of results

Partially published


Result

URL related to results and publications

https://tocms.ait231.tokushima-u.ac.jp/tocms/detail_houkoku.php?rireki_id=8481&houkoku_id=7306&syous

Number of participants that the trial has enrolled

60

Results

During mechanical mask ventilation, ventilation was maintained at a lower inspiratory pressure with the PCV-VG ventilation volume setting of 8 ml/kg than with the PCV inspiratory pressure of 15 cm H2O.
In addition, PCV-VG had a higher percentage of proper ventilation volume and less gastric gas insufflation.

Results date posted

2024 Year 01 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Adults undergoing general anesthesia

Participant flow

After induction of general anesthesia, patients were randomly assigned to be ventilated at PCV inspiratory pressure of 15 cm H2O during mechanical mask ventilation or at PCV-VG ventilation volume setting of 8 ml/kg.
Ventilation volume, inspiratory pressure, and carbon dioxide concentration were measured during mask ventilation.

Adverse events

None

Outcome measures

Inspiratory pressure is lower with PCV-VG.
Adequate ventilation is obtained at a higher rate with PCV-VG.
Gastric gas insufflation is higher with PCV

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 01 Month 01 Day

Date of IRB

2019 Year 02 Month 28 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2022 Year 01 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

2018 Year 11 Month 24 Day

Last modified on

2024 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039901


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name