UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery.
Title of the study (Brief title)	Continuous monitoring of changes in cuff pressure of the tracheal tube during laparoscopic and open abdominal surgery.
Region	Japan

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

Objectives
Narrative objectives1	By monitoring the cuff pressure during laparoscopic and open abdominal surgery continuously , 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 from the start of pneumoperitoneum and start of the surgery to 15 minutes
Key secondary outcomes	Presence or absence of pharyngalgia, dysphagia, hoarseness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	The cuff pressure measurement using the cuff pressure gauge
Interventions/Control_2	The cuff pressure measurement using the cuff pressure gauge
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	21 years-old <=
Age-upper limit	87 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	Kanazawa University Hospital
Division name	Department of anesthesia
Address	13-1 Takaramachi, Kanazawa-shi, Ishikawa-ken
TEL	076-265-2434
Email	impulse1225@yahoo.co.jp

Public contact
Name of contact person	Takashi Tennichi
Organization	Kanazawa University Hospital
Division name	Department of anesthesia
Address	13-1 Takaramachi, Kanazawa-shi, Ishikawa-ken
TEL	076-265-2434
Homepage URL
Email	impulse1225@yahoo.co.jp

Sponsor
Institute	Komatsu Municipal Hospital
Institute
Department

Funding Source
Organization	none
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	2017 Year 09 Month 05 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	2017 Year 07 Month 02 Day
Date analysis concluded	2017 Year 08 Month 25 Day

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Publication of results	Unpublished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

Management information
Registered date	2017 Year 09 Month 05 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033181