UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042884
Receipt number 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 06:31:05

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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 or person

Institute

Chiba university hospital

Institute

Department

Personal name



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

Value
https://center6.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