UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Utility of the nasal high flow oxygen therapy in bronchoscopy.
Title of the study (Brief title)	Utility of the nasal high flow oxygen therapy in bronchoscopy.
Region	Japan

Condition
Condition	The patients who will receive bronchoscopic examination with or without an obstructive lung disease, a restrictive lung disease, and/or hypoxemia.
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The patients will be randomly assigned to the groups of nasal cannula's oxygen therapy and nasal high flow oxygen therapy. We evaluate the utility and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Utility 1: Changes of SpO2 of the patients during bronchoscopy. 2: The rate of inspection discontinuation. 2) Safety 1: The period of bronchoscopic examination. 2: The percentage of pneumothorax, and necessary of mechanical ventilation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	HIGH FLOW THERAPY SYSTEM MAX Venturi Pacific Medico Co., Ltd.
Interventions/Control_2	Nasal Cannula
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients age is more than 20 years old. 2. Patient to perform bronchoscopy, and having either obstructive lung disease, restrictive lung disease, and hypoxemia. 3. Patients with hospitalization or hospitalization after examination. 4. Patients with 5 L/min or less in nasal cannula therapy. 5. Informed consent.
Key exclusion criteria	1. Patients with pneumothorax 2. The type 2 respiratory failure patient who needs respirator management. 3. The patient who has difficulty in oxygen dosage from a nose. 4. If the patient's written consent cannot be obtained. 5. Patients judged to be inappropriate for the study by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Taku Oikawa
Organization	Kanazawa Medical University
Division name	Respiratory Medicine
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Email	t-oikawa@kanazawa-med.ac.jp

Public contact
Name of contact person	Taku Oikawa
Organization	Kanazawa Medical University
Division name	Respiratory Medicine
Address	1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL	076-286-2211
Homepage URL
Email	t-oikawa@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Kanazawa Medical University
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	金沢医科大学

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 23 Day
Anticipated trial start date	2012 Year 12 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 01 Day

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

Management information
Registered date	2012 Year 12 Month 20 Day
Last modified on	2018 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011249