UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042884
Receipt No. R000048946
Scientific Title A study on peak pressure of air leak test in lung surgery
Date of disclosure of the study information 2021/01/02
Last modified on 2021/01/02

* 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 A study on peak pressure of air leak test in lung surgery
Acronym A study on peak pressure of air leak test in lung surgery
Scientific Title A study on peak pressure of air leak test in lung surgery
Scientific Title:Acronym A study on peak pressure of air leak test in lung surgery
Region
Japan

Condition
Condition Lung disease
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In lung surgery, the presence or absence of air leak is checked after lobectomy, and the pressure required for this is defined as the "leak test pressure", and a discussion of the appropriate leak test pressure should be provided.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum leak test pressure and duration of postoperative drain placement
Key secondary outcomes Comparison of maximal leak test pressure and postoperative drain placement duration surgical technique, presence of respiratory complications, high leak test pressure group and low leak test pressure group.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Respiratory surgery performed at our hospital.
Key exclusion criteria Mediastinal tumor.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Son
Middle name
Last name Kyonsu
Organization Chiba university hospital
Division name Anesthesiology, pain and palliative care medicine
Zip code 260-8677
Address Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL 0432227171
Email ccpa0908@chiba-u.jp

Public contact
Name of contact person
1st name Hiroto
Middle name
Last name Chikubu
Organization Chiba university hospital
Division name Anesthesiology,pain and palliative care medicine
Zip code 260-8677
Address Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL 0432227171
Homepage URL
Email ccpa0908@chiba-u.jp

Sponsor
Institute Chiba university hospital
Institute
Department

Funding Source
Organization None
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 Chiba university hospital Clinical research center
Address Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
Tel 0432227171
Email ccpa0908@chiba-u.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
2021 Year 01 Month 02 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 28
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
2020 Year 09 Month 28 Day
Date of IRB
2020 Year 09 Month 28 Day
Anticipated trial start date
2020 Year 09 Month 28 Day
Last follow-up date
2020 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective research

Management information
Registered date
2021 Year 01 Month 02 Day
Last modified on
2021 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048946

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.