UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Respiratory status with respect to the ventilation methods during anesthesia for tracheobronchial stenting Spontaneous respiration vs Controlled ventilation with muscle relaxants : a prospective randomized analysis
Title of the study (Brief title)	Roc-Stent
Region	Japan

Condition
Condition	airway stenosis
Classification by specialty	Pneumology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verify the incindence of desaturation in anesthesia management of airway obstruction ,spontaneous respiration vs controlled ventilation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Whether there is a significant defference in incidence of desaturation between the 2 groups of airway stenting.
Key secondary outcomes	Whether there is a significant defference in intraoperative pH, PaCO2, P/F ratio between the 2 groups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Treat the patients with spontaneous respiration in anesthesia management of airway stenting.
Interventions/Control_2	Treat the patients with controlled ventilation in anesthesia management of airway stenting.
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	Patients who are scheduled tracheal stenting in our hospital for aiway stenosis by malignant neoplasm. Patients of 20 years of age or more Patients who consent to this operation
Key exclusion criteria	Obesity patients (BMI>=30) Patients who have esophagobronchial fistula Patients with desaturation even under oxygen administration Patients who are intubated before the opration Patients with anterior mediastinal tumor-related stenosis Pregnant patients Patients who have an allergy to rocuronium, sugammadex, or other anesthetic agents Patients who have myasthenia gravis or myasthenic syndrome Patients who have organic diseases of brain and cannot measuring the BIS value Patients who have severe allergy desease Patients who are decided unsuitable by doctor in charge of this study from other reasons.
Target sample size	66

Research contact person
Name of lead principal investigator	Akira Tomita
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Anesthesiology
Address	4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL	052-951-1111
Email	tomitaa@nnh.hosp.go.jp

Public contact
Name of contact person	Sakura Okamoto
Organization	National Hospital Organization Nagoya Medical Center
Division name	Department of Anesthesiology
Address	4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL	052-951-1111
Homepage URL
Email	sakura12@nnh.hosp.go.jp

Sponsor
Institute	National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Nagoya Medical Center
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	独立行政法人　国立病院機構　名古屋医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 04 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 04 Month 01 Day
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 03 Month 04 Day
Last modified on	2016 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024079