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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031992
Receipt No. R000036516
Scientific Title The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Date of disclosure of the study information 2018/04/01
Last modified on 2019/03/08

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Basic information
Public title The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Acronym The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Scientific Title The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Scientific Title:Acronym The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Region
Japan

Condition
Condition Adult patients undergoing elective surgery over 6 hours under general anesthesia
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Obsterics and gynecology Orthopedics Anesthesiology
Neurosurgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the estimated arterial partial pressure of carbon dioxide assessed by volumetric capnography to arterial partial pressure of carbon dioxide measured by arterial blood gas.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation coefficient for the estimated arterial partial pressure of carbon dioxide assessed by volumetric capnography and arterial partial pressure of carbon dioxide measured by arterial blood gas.
Key secondary outcomes dead space to tidal volume ratio

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients scheduled for elective surgery in the supine position
Key exclusion criteria Patients with forced expiratory volume in one second < 70%
Patients undergoing one lung ventilation
Patients undergoing cardiopulmonary bypass
Patients with abnormal pulmonary blood flow by congenital heart disease
Patients with less than 50% of ejection fraction
Patients whose invasive blood pressure monitoring can not measured
Patients with difficult airway
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Araki Hiroshi
Organization National Hospital Organization(NHO) Nagasaki Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-1001-1 Kubara,Omura,Nagasaki,856-8562,Japan
TEL 0957-52-3121
Email haraki@nagasaki-mc.com

Public contact
Name of contact person
1st name
Middle name
Last name Araki Hiroshi
Organization National Hospital Organization(NHO) Nagasaki Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-1001-1 Kubara,Omura,Nagasaki,856-8562,Japan
TEL 0957-52-3121
Homepage URL
Email haraki@nagasaki-mc.com

Sponsor
Institute National Hospital Organization(NHO) Nagasaki Medical Center
Institute
Department

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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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 Observational study

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036516

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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