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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021346
Receipt No. R000024079
Scientific Title 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
Date of disclosure of the study information 2016/04/01
Last modified on 2016/09/06

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Basic information
Public title 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
Acronym Roc-Stent
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Akira Tomita
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Anesthesiology
Zip code
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
1st name
Middle name
Last name Sakura Okamoto
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 03 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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