UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study about clinical factors of oxygenation impairment after surgical lung biopsy for interstitial lung disease
Acronym	A retrospective study about clinical factors of oxygenation impairment after surgical lung biopsy for interstitial lung disease
Scientific Title	A retrospective study about clinical factors of oxygenation impairment after surgical lung biopsy for interstitial lung disease
Scientific Title:Acronym	A retrospective study about clinical factors of oxygenation impairment after surgical lung biopsy for interstitial lung disease
Region	Japan

Condition
Condition	Interstitial lung disease
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to investigate clinical factors predictive for impaired oxygenation after surgical lung biopsy for interstitial pneumonia.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oxygen dependency on the day after the surgery
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients who underwent surgical lung biopsy for interstitial pneumonia and admitted to ICU.
Key exclusion criteria	The patients who did not admit to ICU.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Natsuhiro Middle name Last name Yamamoto
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Anesthesiology
Zip code	236-0051
Address	6-16-1Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-701-9581
Email	natsuyamamo@gmail.com

Public contact
Name of contact person	1st name Masahiro Middle name Last name Gamo
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Anesthesiology
Zip code	236-0051
Address	6-16-1Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-701-9581
Homepage URL
Email	gamo@nn.iij4u.or.jp

Sponsor
Institute	Kanagawa Cardiovascular and Respiratory Center
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	Kanagawa Cardiovascular and Respiratory center IRB
Address	6-16-1Tomioka-higashi, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel	045-701-9581
Email	gamo@nn.iij4u.or.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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 15 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	114
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	Completed
Date of protocol fixation	2016 Year 11 Month 30 Day
Date of IRB	2016 Year 11 Month 30 Day
Anticipated trial start date	2016 Year 11 Month 30 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study investigated oxygenation impairment on the day after the surgery. The comparison of clinical factors between those who depended oxygen supplementation and not depended revealed several factors responsible for oxygenation impairment.

Management information
Registered date	2020 Year 01 Month 15 Day
Last modified on	2020 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044673