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

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 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


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

Value
https://center6.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