UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharyngeal cannulae as a new oxygen delivery method; comparison to nasal vannulae
Title of the study (Brief title)	Pharyngeal cannulae as a new oxygen delivery method
Region	Japan

Condition
Condition	Hypoxia during upper gastrointestinal endoscopy in sedated patients
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	During sedation for upper gastrointestinal endoscopy, oxygen supplementation with nasal cannulae (NC) is frequently necessary to prevent hypoxia. A mannequine study we previously performed showed pharyngeal cannulae (PC) provided higher oxygen consentration than NC. This study is aimed to show PC can privide higher oxygen fraction than NC in real patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fraction of inspired oxygen during oxygen delivery via PC or NC, which is mearsured with direct sampling of tracheal gas by cricothyroid ligament puncture catheter
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Oxygen is administrated via a catherter inserted from nose to pharyngeal space at 4 L/min. After preoxygenation (more than 5 minutes), FIO2 is measured for 1 minute by sampling from tracheal catherter. Second measurement is performed in the same way.
Interventions/Control_2	Oxygen is administrated via a nasal cannula at 4L/min. After preoxygenation (more than 5 minutes), FIO2 is measured for 1 minute by sampling from tracheal catherter. Second measurement is performed in the same way.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who were inserted minitracheostomy tubes after extubation of oral endotracheal tubes would be recruited into this study. Participants needs to be awake and be able to understand and consent to this study.
Key exclusion criteria	Exclusion criteria includes patients with anatomical abnormality of nose and pharynx, respiratory diseases, unstable circulatory status, severe hypoxia. In addition, patients who are judged to unsuitable to this study would be also excluded.
Target sample size	10

Research contact person
Name of lead principal investigator	Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Department of Anesthesiology and Intensive Care Unit
Address	3-9, Fukura, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0004, Japan
TEL	81457872918
Email	anesthes@yokohama-cu.ac.jp

Public contact
Name of contact person	Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Department of Anesthesiology and Intensive Care Unit
Address	3-9, Fukura, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0004, Japan
TEL	81457872918
Homepage URL
Email	anesthes@yokohama-cu.ac.jp

Sponsor
Institute	Department of Anesthesiology and Intensive Care Unit, Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Yokohama City University Hospital
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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 17 Day
Anticipated trial start date	2015 Year 10 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

Management information
Registered date	2015 Year 10 Month 02 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022209