UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031533
Receipt number R000035066
Scientific Title Evaluation of perioperative respiratory management after lung resection using displacement sensor
Date of disclosure of the study information 2018/03/01
Last modified on 2021/09/25 21:35:19

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Basic information

Public title

Evaluation of perioperative respiratory management after lung resection using displacement sensor

Acronym

Respiratory management after lung resection with displacement sensor

Scientific Title

Evaluation of perioperative respiratory management after lung resection using displacement sensor

Scientific Title:Acronym

Respiratory management after lung resection with displacement sensor

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

1) Verify the accuracy of thorax orintercostal muscle movement measurement by displacement sensor.
2)Visualize changes in respiratory state from accumulated information and aim at sharing information.
3) Analyze the analysis result and actual clinical information and verify whether prevention and early detection of postoperative pulmonary complications are possible

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between measured respiratory measurements and postoperative respiratory complications within 7 days after surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

method
Measurement method: Install a displacement sensor with a pad similar to the electrocardiogram so as to cross obliquely across the 6th and 9th intercostal spaces on both sides. For the operative side, when overlapping with the post-operative drain insertion site, the deviation of one intercostal space is allowed as the setting range.
For the displacement sensor and the dedicated PC, it is transmitted by wire. Since it is installed at each place on both sides, data acquisition and management are performed with 2ch input / output.
Mainly on data acquisition on the bed, monitor is interrupted during walking and rehabilitation.
The wired lead part is connected via an adapter in order to facilitate attachment / detachment / connection of the connection with the PC. In case

Measurement period: From immediately after surgery to 5 days after surgery. If the condition is satisfied, the measurement may be terminated at an early stage.

Interventions/Control_2

Normal group: preoperative pulmonary function,% FEV 1,% VC not decreasing.
Low lung function group: Those which do not meet standards in the respiratory function test defined above. Or, it was pointed out in interpretation of interstitial pneumonia by radiation radiology in preoperative CT images.
Register for 30 cases in each group.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1.A non-small cell lung cancer patient who is scheduled to perform a pulmonary resection operation
2.Those who are not diagnosed with pulmonary emphysema/interstitial pneumonia due to preoperative examination and do not show decreased respiratory function.
3.The presence of interstitial pneumonia is confirmed on the image. Information that can be observed for more than 30 days after surgery, information such as patient background, perioperative factor, prognosis, presence or absence of acute exacerbation can be obtained or expected to be possible. Those that are expected to be able to acquire these information even in the case of death within 30 days.
4.For preclinical pulmonary function tests, those classified as 2 degree or more (%FEV1 <70%) by Gold classification are targeted. It does not matter whether or not internal or inhalation therapy for pulmonary emphysema is present. It is possible to observe 30 days or more postoperatively, and information such as patient background, perioperative factor, prognosis etc. can be acquired or expected to be possible. Those that are expected to be able to acquire these information even in the case of death within 30 days.
5.Agreement When aged 20 years or older
6.Patients who gave sufficient consultation on participation of this study and obtained consent

Key exclusion criteria

1)There is a history of allergy to the material
2)not attach sensor due to complications of skin diseases
3)difficult to self-decide due to dementia, disorientation of consciousness, etc.
4) Other cases that the investigator considered to be inappropriate as the subject of this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kobayashi Masashi

Organization

Tokyo Medical and Dental University

Division name

Thoracic Surgery

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-0375

Email

mkobthsr@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kobayashi Masashi

Organization

Tokyo Medical and Dental University

Division name

Thoracic Surgery

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-0375

Homepage URL


Email

mkobthsr@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

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


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



Other administrative information

Date of disclosure of the study information

2018 Year 03 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

2017 Year 12 Month 01 Day

Date of IRB

2018 Year 03 Month 01 Day

Anticipated trial start date

2018 Year 03 Month 15 Day

Last follow-up date

2021 Year 03 Month 15 Day

Date of closure to data entry

2022 Year 09 Month 30 Day

Date trial data considered complete

2022 Year 10 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2021 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035066


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name