UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021346 |
|---|---|
| Receipt number | 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 16:05:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
sakura12@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024079
