UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038481
Receipt No. R000043849
Scientific Title Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Date of disclosure of the study information 2019/11/03
Last modified on 2019/11/02

* 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 Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Acronym Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Scientific Title Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Scientific Title:Acronym Usefulness of Jackson Mask Ventilation during Bronchoscopy in Patients Presenting with Acute Respiratory Failure
Region
Japan

Condition
Condition acute respiratory failure
Classification by specialty
Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the usefulness of Jackson mask ventilation in bronchoscopy of patients with ARF
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oxygenation during bronchoscopy
Key secondary outcomes oxygen flow rate during bronchoscopy, inspection time, amount of the drug for sedation, and complications rate after inspection

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The adult patients who were undergone bronchoscopy in our institute from January 2015 to May 2018
2) patients had ARF status before and during bronchoscopy

Also, each group has definied the following criteria.

3) If patients did without Jackson mask ventilation, they needed ARF status before bronchoscopy.
4) If patients did with Jackson mask ventilation, they needed ARF status before and during bronchoscopy.
Key exclusion criteria 1) the patients who needed intubation
2) the patients who were using Jackson mask ventilation preventively
3) the patients who principal investigator deemed inappropriate for incorporation into research
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Suzuki
Organization National Center for Global Health and Medicine
Division name Respiratory
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Email msuzuki@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Takumida
Organization National Center for Global Health and Medicine
Division name Respiratory
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email htakumida@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board of National Center for Global Health and Medicine
Address 1-21-1 Toyama, shinzyuku,Tokyo 162-8655, Japan
Tel 03-3202-7181
Email kenkyu-shinsa@hosp.ncgm.go.jp

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 国立研究開発法人 国立国際医療研究センター

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 03 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 25
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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 11 Day
Date of IRB
2019 Year 10 Month 11 Day
Anticipated trial start date
2019 Year 10 Month 11 Day
Last follow-up date
2019 Year 10 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective study. We extract the following medical information from the medical records.

Back grounds, Vital signs before and during bronchoscopy, Respiratory status, Type and amount of drugs used for sedation, Final diagnosis, Complications, and Outcome

Management information
Registered date
2019 Year 11 Month 02 Day
Last modified on
2019 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043849

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.