UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The estimation of partial pressure of arterial carbon dioxide assessed by volumetric capnography
Title of the study (Brief title)	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	Araki Hiroshi
Organization	National Hospital Organization(NHO) Nagasaki Medical Center
Division name	Department of Anesthesiology
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	Araki Hiroshi
Organization	National Hospital Organization(NHO) Nagasaki Medical Center
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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