UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025270
Receipt number R000029043
Scientific Title Efficacy of alveolar recruitment using flow-volume curve during artificial respiration
Date of disclosure of the study information 2016/12/14
Last modified on 2022/12/23 19:08:20

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Basic information

Public title

Efficacy of alveolar recruitment using flow-volume curve during artificial respiration

Acronym

Efficacy of alveolar recruitment

Scientific Title

Efficacy of alveolar recruitment using flow-volume curve during artificial respiration

Scientific Title:Acronym

Efficacy of alveolar recruitment

Region

Japan


Condition

Condition

healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy of alveolar recruitment during artificial respiration analyzed by using flow-volume curve

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

tidal volume

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

alveolar recruitment

Interventions/Control_2


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

13 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients underwent elective general anesthesia with artificial respiration

Key exclusion criteria

Patients had the severe inspiratory impairment

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Akiko
Middle name
Last name Nishimura

Organization

Showa University

Division name

School of Dentistry, Department of Perioperative Medicine, Division of Anesthesiology

Zip code

145-8515

Address

2-1-1 Kitasenzoku, Ota-ku, Tokyo

TEL

03-3787-1151

Email

nishim@dent.showa-u.ac.jp


Public contact

Name of contact person

1st name Akiko
Middle name
Last name Nishimura

Organization

Showa University

Division name

School of Dentistry, Department of Perioperative Medicine, Division of Anesthesiology

Zip code

145-8515

Address

2-1-1 Kitasenzoku, Ota-ku, Tokyo

TEL

03-3787-1151

Homepage URL


Email

nishim@dent.showa-u.ac.jp


Sponsor or person

Institute

Showa University

Institute

Department

Personal name



Funding Source

Organization

Showa University

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

Showa Universuty Dental Hospital IRB

Address

2-1-1 Kitasenzoku, Ota-ku, Tokyo

Tel

03-3787-1151

Email

ctsc.admin@ofc.showa-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

2016 Year 12 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

48

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 07 Month 19 Day

Date of IRB

2016 Year 12 Month 14 Day

Anticipated trial start date

2016 Year 12 Month 14 Day

Last follow-up date

2022 Year 12 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

2016 Year 12 Month 14 Day

Last modified on

2022 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029043


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name