UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective assessment of continuous positive airway pressure on arterial blood gases during one-lung ventilation
Title of the study (Brief title)	Effects of continuous positive airway pressure on arterial blood gases during one-lung ventilation
Region	Japan

Condition
Condition	lung cancer,esophageal cancer
Classification by specialty	Gastrointestinal surgery Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To measure changes in blood oxygen partial pressure for changing of administration oxygen concentration of CPAP during the one lung ventilation retrospectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood oxygen partial pressure during one-lung ventilation in 30 minutes
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with lung tumor or esophageal tumor
Key exclusion criteria	History of ischemic heart disease. History of ischemic brain disease. NYHA (New York Heart Association) classification is greater than 2. Hugh-Jones classification is greater than 2. SPO2 is less than 95%. PaO2 is less than 70mmHg. BMIis greater than 29 kg/m2. ASA-PS classificationis greater than 2.
Target sample size	13

Research contact person
Name of lead principal investigator	Yuko Yamada
Organization	Gifu University Hospital
Division name	Department of Anesthesiology and pain medicine
Address	1-1 yanagido gifu city
TEL	058-230-6404
Email	y-comet@wg7.so-net.ne.jp

Public contact
Name of contact person	Yamada Yuko
Organization	Gifu University Hospital
Division name	Department of Anesthesiology and pain medicine
Address	1-1 yanagido gifu city
TEL	058-230-6404
Homepage URL
Email	y-comet@wg7.so-net.ne.jp

Sponsor
Institute	Department of Anesthesiology and Pain medicine, Gifu University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 04 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Continuous positive airway pressure of oxygen concentration 50% significantly improved arterial oxygenation during one-lung ventilation.

Management information
Registered date	2016 Year 04 Month 15 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025286