UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes of cuff pressure of the the tracheal tube during pneumoperitoneum.
Title of the study (Brief title)	Changes of cuff pressure of the the tracheal tube during pneumoperitoneum.
Region	Japan

Condition
Condition	Patients undergoing laparoscopic surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By measuring the cuff pressure during laparoscopic surgery , in order to investigate the effect of the cuff pressure by pneumoperitoneum.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the cuff pressure before pneumoperitoneum,during pneumoperitoneum, and after pneumoperitoneum
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	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The cuff pressure measurement using the cuff pressure gauge
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	21 years-old <=
Age-upper limit	82 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who obtained the consent
Key exclusion criteria	Patients who did not obtain the consent
Target sample size	50

Research contact person
Name of lead principal investigator	Takashi Tennichi
Organization	Komatsu Municipal Hospital
Division name	Department of medical care
Address	Mukaimotoorimachi, Ho60, Komatsu-shi, Ishikawa-ken
TEL	0761-22-7111
Email	impulse1225@yahoo.co.jp

Public contact
Name of contact person	Takashi Tennichi
Organization	Komatsu Municipal Hospital
Division name	Department of medical care
Address	Mukaimotoorimachi, Ho60, Komatsu-shi, Ishikawa-ken
TEL	0761-22-7111
Homepage URL
Email	impulse1225@yahoo.co.jp

Sponsor
Institute	Komatsu Municipal 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	none
Organization
Division
Category of Funding Organization	Local Government
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 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 10 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	2016 Year 04 Month 29 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023046