UMIN-CTR Clinical Trial

Basic information
Public title	Oxygen mask with capnometry is useful for CO2 monitoring after surgery.
Acronym	Usefulness of oxygen mask with capnometry
Scientific Title	Oxygen mask with capnometry is useful for CO2 monitoring after surgery.
Scientific Title:Acronym	Usefulness of oxygen mask with capnometry
Region	Japan

Condition
Condition	thoracic and abdominal tumor
Classification by specialty	Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to make a study whether oxygen mask with capnometry is able to be alternative device with arterial blood gas analysis for assessment of respiratory condition after surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The relationship between end tidal carbon dioxide and partial pressure of carbon dioxide in blood. After administration of oxygen as 6 liter per min , 5 liter per min and 4 liter per min for 30 mins respectively, make comparison between end tidal and blood carbon dioxide.
Key secondary outcomes	Make comparison of dissociation between end tidal carbon dioxide and partial pressure of carbon dioxide during deep breath in oxygen administration as 6 liter per min, 5 liter per min and 4 liter per min.

Base
Study type

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Rather than the normal oxygen mask, to perform the oxygen administration by oxygen mask with capnometry.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	I intend for adult patients who are extubated in the operating room in the postoperative patient Hepatobiliary and pancreatic disease.
Key exclusion criteria	I exclude patients who are state of consternation and respiratory depression due to chronic obstructive pulmonary disease and lung resection, under 18 years of age and serious injuries lung disease.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Intensive Care Unit
Zip code
Address	3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL	045-787-2800
Email	shunty5323@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Intensive Care Unit
Zip code
Address	3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL	0457872800
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama City University Hospital Department of Anesthesiology
Institute
Department

Funding Source
Organization	Yokohama City University Hospital Department of Anesthesiology
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
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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://rc.rcjournal.com/content/early/2015/01/13/respcare.03557
Number of participants that the trial has enrolled
Results	Oxygen mask capnometry type may be useful for respiratory monitoring. Absolute value of EtCO2 was widely variable, therefore it is suitable for monitoring of transition of CO2 value.
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	Main results already published
Date of protocol fixation	2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 10 Day
Last follow-up date	2014 Year 01 Month 10 Day
Date of closure to data entry	2014 Year 10 Month 10 Day
Date trial data considered complete	2014 Year 11 Month 10 Day
Date analysis concluded	2014 Year 12 Month 10 Day

Other
Other related information

Management information
Registered date	2013 Year 10 Month 01 Day
Last modified on	2015 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013922

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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