UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	study on the cuff pressure of endotracheal tube
Title of the study (Brief title)	study on the cuff pressure of endotracheal tube
Region	Japan

Condition
Condition	Disease with the need of the surgical intervention
Classification by specialty	Surgery in general Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clinical experience has been thought to correct cuff pressure (CP) more appropriately. Cuff volume (CV) is thought to affect CP during airway management. Moreover, it has still been unclear the relation between CP and CV under general anesthesia. We investigate the differences developing from experience about CP and CV using the endotracheal tube.
Basic objectives2	Others
Basic objectives -Others	It is recommended to maintain cuff pressure between 20 - 30 cm H2O. While insufficient cuff pressure(CP) of endotracheal tube may lead to aspiration, excessive CP may damage the tracheal epithelium. palpation method with pilot balloon did not result in adequate CP. The aim of this stusy is that this method is able to provide proper CP.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cuff pressure and cuff volume of single-lumen tube under general anesthesia, and experience level as an anesthesiologist
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria were patients who were required elective and non-elective surgery under general anesthesia.
Key exclusion criteria	Exclusion criteria were patients who were in under 18 years, damaged cuff after intubation, intubated before anesthetic induction, tracheostomy, or administered N2O.
Target sample size	400

Research contact person
Name of lead principal investigator	Nozomu Hiraoka
Organization	Jichi Medical University Hospital
Division name	Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Address	Yakushiji 3311-1, Shimotsuke-shi, Tochigi-ken, Japan
TEL	0285-58-7383
Email	nonhiraoka@yahoo.co.jp

Public contact
Name of contact person	Nozomu Hiraoka
Organization	Jichi Medical University Hospital
Division name	Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Address	Yakushiji 3311-1, Shimotsuke-shi, Tochigi-ken, Japan
TEL	0285-58-7383
Homepage URL
Email	nonhiraoka@yahoo.co.jp

Sponsor
Institute	Jichi Medical University Hospital Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
Institute
Department

Funding Source
Organization	Jichi Medical University Hospital Division of Anesthesiology, Department of Anesthesiology and Critical Care Medicine
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 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 05 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	A total of 250 patients were enrolled in the current study.

Management information
Registered date	2017 Year 06 Month 15 Day
Last modified on	2017 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031816