UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019919
Receipt number R000022997
Scientific Title Determination for Optimal Ventilator Settings Using Deadspace Analysis by Volumetric Capnography
Date of disclosure of the study information 2015/11/25
Last modified on 2017/11/25 11:22:44

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Basic information

Public title

Determination for Optimal Ventilator Settings Using Deadspace Analysis by Volumetric Capnography

Acronym

Determination for Optimal Ventilator Settings Using Deadspace Analysis

Scientific Title

Determination for Optimal Ventilator Settings Using Deadspace Analysis by Volumetric Capnography

Scientific Title:Acronym

Determination for Optimal Ventilator Settings Using Deadspace Analysis

Region

Japan


Condition

Condition

Patients reseived general anesthesia using artificial controred ventilation

Classification by specialty

Pneumology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Determination for Optimal Ventilator Settings Using Deadspace Analysis by Volumetric Capnography.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

respiratory deadspace at the time of 30minutes after the ventilatory setting

Key secondary outcomes

phisiological deadspace


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Alteration of end-inspiratory-pause
(EIP%),20%,30%,40%,50%.
30minutes duraion ofeach EIP.

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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Scheduled operation patient who will be received general anaesthesia.

Key exclusion criteria

Patients who have heart failure or respiratory failure at the preoperating examination.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nagahide Yoshida

Organization

Saiseikai Maebashi Hospital

Division name

Department of anaesthesiology

Zip code


Address

564-1 kamishinden-machi,maebashi,gunma

TEL

027-252-6011

Email

totemkopf@hotmail.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nagahide Yoshida

Organization

Saiseikai Maebashi Hospital

Division name

Department of anaesthesiology

Zip code


Address

564-1 kamishinden-machi,maebashi,gunma

TEL

027-252-6011

Homepage URL


Email

totemkopf@hotmail.co.jp


Sponsor or person

Institute

Saiseikai Maebashi Hospital

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


Address


Tel


Email



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

済生会前橋病院(群馬県)


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 25 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


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

Terminated

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 24 Day

Last modified on

2017 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022997