UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on changes in endotracheal tube cuff pressure during tracheal intubation
Title of the study (Brief title)	A study on changes in endotracheal tube cuff pressure during tracheal intubation
Region	Japan

Condition
Condition	adult patients presenting for elective surgery under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test if endotracheal tube cuff pressure profile could enable us to detect esophageal intubation during tracheal intubation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	endotracheal tube cuff pressure profile during intubation
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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	inflation of endotracheal tube cuff with 1ml of air before tracheal intubation
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	American Society of Anesthesiologists physical status 1-2 patients presenting for elective surgery under general anesthesia with orotracheal intubation
Key exclusion criteria	Those who have any wound or lesion or abnormality or foreign objects at maxillofacial or cervical or upper airway or respiratory region. Pregnant women. Those who cannot express their will to participate in the study by themselves. Emergent operations. Full stomach condition or alike (e.g. obese patients whose body mass index is above 35, those who have large abdominal mass, etc.)
Target sample size	100

Research contact person
Name of lead principal investigator	Yugo Tagaito
Organization	Teikyo University Chiba Medical Center
Division name	Department of Anesthesiology
Address	3426-3 Anesaki, Ichihara-city, Chiba, Japan
TEL	0436-62-1211
Email	ytagaito@yahoo.co.jp

Public contact
Name of contact person	Yugo Tagaito
Organization	Teikyo University Chiba Medical Center
Division name	Department of Anesthesiology
Address	3426-3 Anesaki, Ichihara-city, Chiba, Japan
TEL	0436-62-1211
Homepage URL
Email	ytagaito@yahoo.co.jp

Sponsor
Institute	Teikyo University
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	2016 Year 12 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 08 Day
Anticipated trial start date	2016 Year 12 Month 14 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 12 Month 13 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029011