UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of recruitment maneuver on functional residual volume and arterial oxygenation during one-lung ventilation
Title of the study (Brief title)	Recruitment maneuver during one-lung ventilation
Region	Japan

Condition
Condition	Lung tumor
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of recruitment maneuver on functional residual volume and arterial oxygenation during one-lung ventilation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Functional residual volume Partial pressure of oxygen in arterial blood
Key secondary outcomes

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Recruitment maneuver is performed to the dependent lung during one-lung ventilation (at 15 minutes) after the surgery started).
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who undergo video-assisted thoracoscopic lung resection and require one-lung ventilation for an hour or longer are included.
Key exclusion criteria	Patients with ischemic heart disease, severe arrhythmia, unstable hemodynamic parameters, interstitial pneumonia, bulla in the dependent lung, history of lobectomy in the dependent lung, severe obstructive lung disease, or tracheostomy are excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	Seiji Ishikawa
Organization	Tokyo Medical and Dental University Hospital of Medicine
Division name	Department of Anesthesiology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5325
Email	ishikawa.mane@tmd.ac.jp

Public contact
Name of contact person	Seiji Ishikawa
Organization	Tokyo Medical and Dental University Hospital of Medicine
Division name	Department of Anesthesiology
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	81-3-5803-5325
Homepage URL
Email	ishikawa.mane@tmd.ac.jp

Sponsor
Institute	Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
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	2012 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 18 Day
Anticipated trial start date	2012 Year 11 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

Management information
Registered date	2012 Year 10 Month 10 Day
Last modified on	2019 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010633